High Flow Nasal Cannula Therapy for Childhood OSA
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
High flow nasal cannula
Continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Therapy, High flow nasal cannula, Children, Adolescents
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of moderate-to-severe OSA requiring CPAP therapy (Moderate-to-severe OSA is defined as an OAHI ≥ 5 events per hour and reported history of habitual snoring of 3 nights or more per week)
Exclusion Criteria:
- Syndromal diseases;
- Cranio-facial anomalies;
- Pathological central apnoea, chronic respiratory failure or neuromuscular disease as they would require bilevel PAP;
- Secondary obesity e.g. Prader-Willi syndrome, Cushing's syndrome;
- History of pneumothorax or pneumomediastinum;
- Prior use of PAP or HFNC therapy;
- Refusal to use non-invasive ventilation.
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High flow nasal cannula (HFNC)
Continuous positive airway pressure (CPAP)
Arm Description
High flow nasal cannula therapy
Continuous positive airway pressure therapy
Outcomes
Primary Outcome Measures
Efficacy of the high flow nasal cannula (HFNC) therapy: the absolute change in obstructive apnea hypopnea index (OAHI) from baseline with the use of HFNC therapy
The change in obstructive apnea hypopnea index (OAHI) from baseline to that on HFNC therapy: obstructive apnoea hypopnoea index is the number of obstructive apnoea or hypopnoea events per hour of total sleep time (It is not a scale, minimum is 0 events/hour, there is no maximum score)
Secondary Outcome Measures
Compliance to the therapy: percentage of subjects who are adherent to the therapy
Percentage of subjects who are adherent to the therapy, which is defined as >70% nightly use and average usage ≥ 4 hours per night
Quality of life measures - Modified Epworth Sleepiness Scale
Modified Epworth Sleepiness Scale (ESS) to assess the daytime sleepiness - ESS score is the sum of the eight item scores ranging from 0 to 24, where a higher score represents greater sleepiness.
Quality of life measures - Pediatric Quality of Life Inventory
Pediatric Quality of Life Inventory (PedsQL) - 23-item PedsQL Generic Core Scales will measure the core dimensions of health as delineated by the World Health Organisation, as well as role functioning. Four dimensions, physical, emotional, social and school functioning, will be measured. For physical functioning, score ranges from 1 to 8. For emotional, social and school functioning, scores range from 1 to 5. Higher scores indicate better quality of life.
Quality of life measures - OSAS-18
OSAS-18 is a questionnaire with composite of OSAS-related symptoms and disease-specific quality of life. Score ranges from 18 to 126; 18 - 60 indicates small impact on health-related quality of life; 60 to 80 indicates moderate impact; >80 indicates severe impact.
Neurobehavioural surveys - Child Behaviour Checklist
Child Behaviour Checklist is a survey of behaviour competencies that yields standardised, age-adjusted scores on internalizing, externalizing and total behaviour difficulties
Full Information
NCT ID
NCT03933800
First Posted
April 23, 2019
Last Updated
September 22, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03933800
Brief Title
High Flow Nasal Cannula Therapy for Childhood OSA
Official Title
High-flow Nasal Cannula as an Alternative Intervention for Children and Adolescents With Obstructive Sleep Apnoea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.
Children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy will be recruited.
In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.
Detailed Description
Background: Obstructive sleep apnoea (OSA) is prevalent in school-aged children and is associated with significant morbidities. Poor compliance with positive airway pressure therapy remains an issue and leads to suboptimal treatment in children with OSA. Alternative therapeutic strategy is needed to manage this group of patients more effectively.
Objective: To evaluate the efficacy of high-flow nasal cannula (HFNC) therapy in children with OSA.
Hypothesis: The investigators hypothesize that HFNC therapy is effective in reducing the severity of OSA in children.
Design: A 2-phase study - phase 1 is a single arm study to evaluate the efficacy of HFNC therapy in children with OSA, phase 2 is an intervention period to evaluate the compliance and quality of life with HFNC therapy.
Subjects: 46 children and adolescents aged 6 to 18 years old with a diagnosis of moderate-to-severe OSA requiring CPAP therapy.
Methods: In phase 1 study, eligible subject will be recruited for HFNC therapy titration with PSG to assess treatment efficacy. After titration, if HFNC therapy is shown to be effective, the participants will be recruited into the phase 2 intervention period to evaluate the compliance and quality of life with HFNC therapy. At baseline and follow-up visits, neurobehavioural and quality of life surveys will be completed, compliance data will be obtained.
Primary outcome measure: Efficacy of the HFNC therapy, as defined by the change in OAHI from baseline to that with HFNC therapy.
Expected results: Efficacy data to determine whether HFNC therapy can be an alternative therapy for children with OSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Therapy, High flow nasal cannula, Children, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula (HFNC)
Arm Type
Experimental
Arm Description
High flow nasal cannula therapy
Arm Title
Continuous positive airway pressure (CPAP)
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure therapy
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
High flow nasal cannula therapy
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Intervention Description
Continuous positive airway pressure therapy
Primary Outcome Measure Information:
Title
Efficacy of the high flow nasal cannula (HFNC) therapy: the absolute change in obstructive apnea hypopnea index (OAHI) from baseline with the use of HFNC therapy
Description
The change in obstructive apnea hypopnea index (OAHI) from baseline to that on HFNC therapy: obstructive apnoea hypopnoea index is the number of obstructive apnoea or hypopnoea events per hour of total sleep time (It is not a scale, minimum is 0 events/hour, there is no maximum score)
Time Frame
One night - titration study will be done overnight for one night to look at the improvement of OAHI from baseline to that with HFNC therapy
Secondary Outcome Measure Information:
Title
Compliance to the therapy: percentage of subjects who are adherent to the therapy
Description
Percentage of subjects who are adherent to the therapy, which is defined as >70% nightly use and average usage ≥ 4 hours per night
Time Frame
3 months
Title
Quality of life measures - Modified Epworth Sleepiness Scale
Description
Modified Epworth Sleepiness Scale (ESS) to assess the daytime sleepiness - ESS score is the sum of the eight item scores ranging from 0 to 24, where a higher score represents greater sleepiness.
Time Frame
3 months
Title
Quality of life measures - Pediatric Quality of Life Inventory
Description
Pediatric Quality of Life Inventory (PedsQL) - 23-item PedsQL Generic Core Scales will measure the core dimensions of health as delineated by the World Health Organisation, as well as role functioning. Four dimensions, physical, emotional, social and school functioning, will be measured. For physical functioning, score ranges from 1 to 8. For emotional, social and school functioning, scores range from 1 to 5. Higher scores indicate better quality of life.
Time Frame
3 months
Title
Quality of life measures - OSAS-18
Description
OSAS-18 is a questionnaire with composite of OSAS-related symptoms and disease-specific quality of life. Score ranges from 18 to 126; 18 - 60 indicates small impact on health-related quality of life; 60 to 80 indicates moderate impact; >80 indicates severe impact.
Time Frame
3 months
Title
Neurobehavioural surveys - Child Behaviour Checklist
Description
Child Behaviour Checklist is a survey of behaviour competencies that yields standardised, age-adjusted scores on internalizing, externalizing and total behaviour difficulties
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of moderate-to-severe OSA requiring CPAP therapy (Moderate-to-severe OSA is defined as an OAHI ≥ 5 events per hour and reported history of habitual snoring of 3 nights or more per week)
Exclusion Criteria:
Syndromal diseases;
Cranio-facial anomalies;
Pathological central apnoea, chronic respiratory failure or neuromuscular disease as they would require bilevel PAP;
Secondary obesity e.g. Prader-Willi syndrome, Cushing's syndrome;
History of pneumothorax or pneumomediastinum;
Prior use of PAP or HFNC therapy;
Refusal to use non-invasive ventilation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate C Chan, MBChB
Phone
35052849
Email
katechan@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate C Chan, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate C Chan, MBChB
Phone
35052849
Email
katechan@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Kate C Chan, MBChB
First Name & Middle Initial & Last Name & Degree
Albert M Li, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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High Flow Nasal Cannula Therapy for Childhood OSA
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