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Dexamethasone Treatment for OSA in Children

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
Placebo Control
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Dexamethasone, Corticosteroid

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour) Aged 2-10 years Presence of adenotonsillar hypertrophy Ability to take oral medication and be willing to adhere to the dosing regimen Informed consent provided in accordance with institutional policies Exclusion Criteria: Previous adenotonsillectomy Presence of symptoms of an upper respiratory tract infection Co-existing central sleep apnea Hypertension Prior or current evidence for abnormal glucose tolerance Contraindication for dexamethasone or components of dexamethasone oral suspension, Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention OSA with associated oxygen desaturations <90% for 2 continuous minutes Need for non-invasive ventilation long-term due to underlying disease Current systemic fungal infections Patients with clinically relevant varicella exposure

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone Treatment

Placebo Treatment

Arm Description

Oral Dexamethasone treatment

Placebo control

Outcomes

Primary Outcome Measures

Obstructive apnea-hypopnea index
Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr

Secondary Outcome Measures

Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Total CSHQ score of 41 has been reported to be a sensitive clinical cut-off point for detecting possible sleep problems
Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a validated parent-reported behavioural screening questionnaire and is used to assess children's mental health. The total difficulties score ranges from 0 to 40, a higher score indicates higher difficulties.
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
The OSA-18 QoL survey is a validated 18-item quality of life measure for children with sleep-disordered breathing (SDB) for children 2-18. Higher total scores indicate more impact on QoL - minor impact (scores below 60), moderate impact (scores between 60 and 80) and major impact (scores above 80).
Soft tissue size (Adenoids, Tonsils & Turbinates)
Change in soft tissue size (adenoids, tonsils and turbinates) from baseline
Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline
Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA
Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)
Cells from nasal brushing will be cultured and harvested for RNA to study gene expression.
Participant recruitment rate
Feasibility determined by participant recruitment rate
Participant retention rate
Feasibility determined by participant retention rate
Participant adherence rate
Feasibility determined by participant adherence rate
Adverse events
Safety determined by number and severity of adverse events

Full Information

First Posted
November 2, 2022
Last Updated
December 1, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT05638087
Brief Title
Dexamethasone Treatment for OSA in Children
Official Title
Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.
Detailed Description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas. The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects. Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown. The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial. Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Dexamethasone, Corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone Treatment
Arm Type
Experimental
Arm Description
Oral Dexamethasone treatment
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone Oral Suspension
Intervention Type
Drug
Intervention Name(s)
Placebo Control
Intervention Description
Placebo Oral Mix
Primary Outcome Measure Information:
Title
Obstructive apnea-hypopnea index
Description
Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr
Time Frame
Baseline and 2-4 weeks
Secondary Outcome Measure Information:
Title
Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Description
Total CSHQ score of 41 has been reported to be a sensitive clinical cut-off point for detecting possible sleep problems
Time Frame
Baseline and 2-4 weeks
Title
Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)
Description
The SDQ is a validated parent-reported behavioural screening questionnaire and is used to assess children's mental health. The total difficulties score ranges from 0 to 40, a higher score indicates higher difficulties.
Time Frame
Baseline and 2-4 weeks
Title
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
Description
The OSA-18 QoL survey is a validated 18-item quality of life measure for children with sleep-disordered breathing (SDB) for children 2-18. Higher total scores indicate more impact on QoL - minor impact (scores below 60), moderate impact (scores between 60 and 80) and major impact (scores above 80).
Time Frame
Baseline and 2-4 weeks
Title
Soft tissue size (Adenoids, Tonsils & Turbinates)
Description
Change in soft tissue size (adenoids, tonsils and turbinates) from baseline
Time Frame
Baseline and 2-4 weeks
Title
Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline
Description
Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA
Time Frame
At baseline
Title
Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)
Description
Cells from nasal brushing will be cultured and harvested for RNA to study gene expression.
Time Frame
At baseline
Title
Participant recruitment rate
Description
Feasibility determined by participant recruitment rate
Time Frame
From study start to completion; up to 6 months
Title
Participant retention rate
Description
Feasibility determined by participant retention rate
Time Frame
From study start to completion; up to 6 months
Title
Participant adherence rate
Description
Feasibility determined by participant adherence rate
Time Frame
From study start to completion; up to 6 months
Title
Adverse events
Description
Safety determined by number and severity of adverse events
Time Frame
From study start to completion; up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour) Aged 2-10 years Presence of adenotonsillar hypertrophy Ability to take oral medication and be willing to adhere to the dosing regimen Informed consent provided in accordance with institutional policies Exclusion Criteria: Previous adenotonsillectomy Presence of symptoms of an upper respiratory tract infection Co-existing central sleep apnea Hypertension Prior or current evidence for abnormal glucose tolerance Contraindication for dexamethasone or components of dexamethasone oral suspension, Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention OSA with associated oxygen desaturations <90% for 2 continuous minutes Need for non-invasive ventilation long-term due to underlying disease Current systemic fungal infections Patients with clinically relevant varicella exposure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mystica Terrance, BSc
Phone
6479261307
Email
mystica.terrance@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indra Narang, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mystica Terrance, BSc
Email
mystica.terrance@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Indra Narang, MD

12. IPD Sharing Statement

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Dexamethasone Treatment for OSA in Children

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