An interventional study of High flow nasal cannula and Continuous positive airway pressure in Obstructive Sleep Apnea, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 32 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
High flow nasal cannula therapy
Device: High flow nasal cannula
Continuous positive airway pressure therapy
Device: Continuous positive airway pressure
High flow nasal cannula therapy
Continuous positive airway pressure therapy
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)
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
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
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong