Back to resultsIntranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children (MIST+)
Primary Purpose
Sleep Disorder; Breathing-Related, Snoring, Obstructive Sleep Apnea of Child
Status
Recruiting
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Mometasone Furoate 50mcg Nasal Spray
Sodium Chloride 0.9 % Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder; Breathing-Related
Eligibility Criteria
Inclusion Criteria:
Each participant must meet all of the following criteria to be enrolled in this trial:
- Is between the ages of 3 and 12 years inclusive at the time of randomisation
- Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
- Has a BMI over the 97th centile for age and gender
- Has a history of tonsillectomy and/or adenoidectomy
- Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
- Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
- Has a history of nasal surgery or trauma which has not fully healed
- Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
- Is assessed to have stertor (snoring) while awake at rest
- Has a known hypersensitivity to the study drug or its formulation
- Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
- Daily use of antihistamine or decongestant nasal sprays
- Is known to require systemic steroids prior to the completion of the study treatment phase
- Has had treatment with any other investigational drug within 6 months prior to randomisation
- Is unable to provide consent without the aid of an interpreter.
- In the opinion of the Investigator may be unable to follow the protocol
Sites / Locations
- Monash Children's HospitalRecruiting
- Royal Children's Hospital / Murdoch Children's Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intranasal Steroids
Intranasal Saline
Arm Description
Outcomes
Primary Outcome Measures
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Secondary Outcome Measures
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)
The Pediatric Sleep Questionnaire - sleep disordered breathing subscale is a validated questionnaire which contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behaviour, and other paediatric Obstructive Sleep Apnoea (OSA) features. Responses are "yes" = 1, "no" = 0, and "don't know"=missing.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).
The Obstructive Sleep Apnoea-18 (OSA-18) questionnaire is a validated questionnaire and consists of 18 questions concerning sleep disturbances, physical symptoms, emotional distress, daytime function, and caregiver concerns.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Strengths and Difficulties Questionnaire (SDQ) is a validated brief behavioural screening questionnaire about 3-16 year olds. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Glasgow Children's Benefit Inventory (GCBI) consists of 24 questions on the consequences of a specified intervention on various aspects of the day-to-day child life, without reference to any specific symptoms, and it can be apply to children of any age. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 18 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 24 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 18 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 24 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who think their child still needs a review by a hospital specialist at 18 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who think their child still needs a review by a hospital specialist at 24 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 18 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 24 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 18 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 24 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 18 months.
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 18 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 24 months.
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 24 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 18 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 18 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 24 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules. The proportion of participants in each treatment arm with resolution of symptoms at 24 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Parents will be emailed a survey with the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration he study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm. of treatment
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 18 months.
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 24 months
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Number of adverse events (AEs) throughout the treatment phase
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Number of adverse events (AEs) within the first week of the treatment
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Bottles will be weighed before they are given to participants and weighed when they are returned. The amount used will be calculated and used to determine if the participant was compliant with dosing. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Compliance with treatment will be calculated as the proportion of prescribed doses over 6 weeks that was consumed based on the weight of the bottles. The mean compliance will be summarised for the run-in period and both treatment arms. The proportion of participants with 80% and more compliance will be given for each treatment arm. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Logistical regression models will be fitted to determine whether clinical factors at baseline or severity of SDB symptoms at baseline were associated with response to the intervention. Treatment arm, the symptom or factor of interest, and the interaction between the treatment arm and the symptom or factor will be included in this model. Symptoms or factors of interest include demographic factors, severity of SDB at baseline, history of atopy and history of tonsillitis.
Full Information
NCT ID
NCT05382494
First Posted
May 16, 2022
Last Updated
March 22, 2023
Sponsor
Murdoch Childrens Research Institute
Collaborators
Monash Health, Royal Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05382494
Brief Title
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
Acronym
MIST+
Official Title
Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute
Collaborators
Monash Health, Royal Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.
Detailed Description
MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive followup at at 12 weeks, 6, 12, 18 and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder; Breathing-Related, Snoring, Obstructive Sleep Apnea of Child, Sleep Disorders in Children, Tonsillar Hypertrophy, Adenoidal Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, double-blind, randomised control trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The saline is the same colour and consistency to the active drug (intranasal steroid) and will have the same sensation when sprayed into the nostril. Randomisation will be stratified by site, Royal Children's Hospital (RCH) and Monash Health (MH), with permuted random block randomisation. An independent statistician in the Clinical Epidemiology and Biostatistics Unit (CEBU) at Murdoch Children's Research Institute (MCRI) will arrange the randomisation schedules, which will be given to the Clinical Trials Pharmacy at RCH and MH. This schedule will remain blinded to all other study staff.
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Steroids
Arm Type
Experimental
Arm Title
Intranasal Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate 50mcg Nasal Spray
Other Intervention Name(s)
Sensease Nasal Allergy Relief Nasal Spray
Intervention Description
Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9 % Nasal Spray
Other Intervention Name(s)
Intranasal Saline Spray
Intervention Description
Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks
Primary Outcome Measure Information:
Title
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
12 weeks
Title
An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)
Description
The Pediatric Sleep Questionnaire - sleep disordered breathing subscale is a validated questionnaire which contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behaviour, and other paediatric Obstructive Sleep Apnoea (OSA) features. Responses are "yes" = 1, "no" = 0, and "don't know"=missing.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Time Frame
6 weeks
Title
An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).
Description
The Obstructive Sleep Apnoea-18 (OSA-18) questionnaire is a validated questionnaire and consists of 18 questions concerning sleep disturbances, physical symptoms, emotional distress, daytime function, and caregiver concerns.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Time Frame
6 weeks
Title
An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Description
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Time Frame
6 weeks
Title
An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Description
The Strengths and Difficulties Questionnaire (SDQ) is a validated brief behavioural screening questionnaire about 3-16 year olds. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Time Frame
6 weeks
Title
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Description
The Glasgow Children's Benefit Inventory (GCBI) consists of 24 questions on the consequences of a specified intervention on various aspects of the day-to-day child life, without reference to any specific symptoms, and it can be apply to children of any age. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Time Frame
6 weeks
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
6 weeks
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
12 weeks
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
6 months
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
12 months
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 18 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
18 months
Title
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 24 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T&A)?"
Time Frame
24 months
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
6 weeks
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
12 weeks
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
6 months
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
12 months
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 18 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
18 months
Title
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 24 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T&A surgery were recommended to you now, would you be happy to proceed?"
Time Frame
24 months
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
6 weeks
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
12 weeks
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
6 months
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
12 months
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 18 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
18 months
Title
Proportion of parents who think their child still needs a review by a hospital specialist at 24 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Time Frame
24 months
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
6 weeks
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
12 weeks
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
6 months
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
12 months
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 18 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
18 months
Title
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 24 months
Description
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Time Frame
24 months
Title
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
Description
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Time Frame
6 weeks
Title
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
Description
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Time Frame
12 weeks
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Description
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
6 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Description
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
12 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 18 months
Description
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
18 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 24 months
Description
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
24 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
6 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
12 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 18 months.
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 18 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
18 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 24 months.
Description
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 24 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
24 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
Description
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
6 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
Description
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
12 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 18 months
Description
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 18 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
18 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 24 months
Description
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules. The proportion of participants in each treatment arm with resolution of symptoms at 24 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Time Frame
24 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Description
Parents will be emailed a survey with the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Time Frame
6 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Description
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration he study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm. of treatment
Time Frame
12 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 18 months.
Description
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Time Frame
18 months
Title
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 24 months
Description
Parents will be asked the following questions about any treatment their child may have had for SDB
Specialty of Dr seen and number of appointments
Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Time Frame
24 months
Title
Number of adverse events (AEs) throughout the treatment phase
Description
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Time Frame
6 weeks
Title
Number of adverse events (AEs) within the first week of the treatment
Description
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Time Frame
1 week
Title
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Description
Bottles will be weighed before they are given to participants and weighed when they are returned. The amount used will be calculated and used to determine if the participant was compliant with dosing. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Compliance with treatment will be calculated as the proportion of prescribed doses over 6 weeks that was consumed based on the weight of the bottles. The mean compliance will be summarised for the run-in period and both treatment arms. The proportion of participants with 80% and more compliance will be given for each treatment arm. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Time Frame
-6 weeks and 6 weeks (start of run-in phase to end of treatment phase)
Title
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Description
Logistical regression models will be fitted to determine whether clinical factors at baseline or severity of SDB symptoms at baseline were associated with response to the intervention. Treatment arm, the symptom or factor of interest, and the interaction between the treatment arm and the symptom or factor will be included in this model. Symptoms or factors of interest include demographic factors, severity of SDB at baseline, history of atopy and history of tonsillitis.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each participant must meet all of the following criteria to be enrolled in this trial:
Is between the ages of 3 and 12 years inclusive at the time of randomisation
Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
Has a BMI over the 97th centile for age and gender
Has a history of tonsillectomy and/or adenoidectomy
Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
Has a history of nasal surgery or trauma which has not fully healed
Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
Is assessed to have stertor (snoring) while awake at rest
Has a known hypersensitivity to the study drug or its formulation
Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
Daily use of antihistamine or decongestant nasal sprays
Is known to require systemic steroids prior to the completion of the study treatment phase
Has had treatment with any other investigational drug within 6 months prior to randomisation
Is unable to provide consent without the aid of an interpreter.
In the opinion of the Investigator may be unable to follow the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten Perrett
Phone
61399366278
Email
kirsten.perrett@rch.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Anderson
Phone
61383416432
Email
deborah.anderson@mcri.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Perrett
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gillian Nixon
Phone
0385723592
Email
gillian.nixon@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Gillian Nixon
Facility Name
Royal Children's Hospital / Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Perrett
Phone
0399366278
Email
kirsten.perrett@rch.org.au
First Name & Middle Initial & Last Name & Degree
Deborah Anderson
Phone
0383416432
Email
deborah.anderson@mcri.edu.au
First Name & Middle Initial & Last Name & Degree
Kirsten Perrett
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified data set that will be collected for this analysis of the MIST+ trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered.
Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institute, which has approved the proposed analysis plan.
IPD Sharing Time Frame
Six months after the publication of the primary outcome
IPD Sharing Access Criteria
Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered.
Learn more about this trial
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
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