Obstructive Sleep ApneaNCT03933800
High Flow Nasal Cannula Therapy for Childhood OSA
A study testing High flow nasal cannula and Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- High flow nasal cannula and Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Cannula as an Alternative Intervention for Children and Adolescents With Obstructive Sleep Apnoea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- High flow nasal cannula, Continuous positive airway pressure
- Keywords
- Therapy, High flow nasal cannula, Children, Adolescents
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
High flow nasal cannula therapy
Continuous positive airway pressureDevice
Continuous positive airway pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula (HFNC) | Experimental | High flow nasal cannula therapy Receives: Device: High flow nasal cannula |
| Continuous positive airway pressure (CPAP) | Active comparator | Continuous positive airway pressure therapy Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jul 2019
- Primary completion15 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Kate C Chan, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933800
- Sponsor's protocol ID
- HFOSA1.0
- Status last verified
- Jun 2024
- First submitted
- 23 Apr 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan KC, Au CT, Kwok KL, Yang M, Yuen NT, Yu MW, Li AM. Efficacy of high-flow nasal cannula therapy and its effectiveness in home settings for paediatric obstructive sleep apnoea. Sleep Med. 2025 Sep;133:106637. doi: 10.1016/j.sleep.2025.106637. Epub 2025 Jun 14.
PubMed 40554388
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula as an Alternative Intervention for Children and Adolescents With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT03933800
- Acronym / sponsor ID
- HFOSA1.0
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Therapy, High flow nasal cannula, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula (HFNC) | Experimental | Device: High flow nasal cannulaHigh flow nasal cannula therapy |
| Continuous positive airway pressure (CPAP) | Active comparator | Device: Continuous positive airway pressureContinuous positive airway pressure therapy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannulaHigh flow nasal cannula therapy | Device | High flow nasal cannula (HFNC) |
| Continuous positive airway pressureContinuous positive airway pressure therapy | Device | Continuous positive airway pressure (CPAP) |
Primary outcome
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
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
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)
5 secondary outcomes
Compliance to the therapy: percentage of subjects who are adherent to the therapy
Time frame: 3 months
Quality of life measures - Modified Epworth Sleepiness Scale
Time frame: 3 months
Quality of life measures - Pediatric Quality of Life Inventory
Time frame: 3 months
Quality of life measures - OSAS-18
Time frame: 3 months
Neurobehavioural surveys - Child Behaviour Checklist
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 40554388Chan KC, Au CT, Kwok KL, Yang M, Yuen NT, Yu MW, Li AM. Efficacy of high-flow nasal cannula therapy and its effectiveness in home settings for paediatric obstructive sleep apnoea. Sleep Med. 2025 Sep;133:106637. doi: 10.1016/j.sleep.2025.106637. Epub 2025 Jun 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate C Chan, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula and Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.