Obstructive Sleep ApneaNCT03843372
High Flow Nasal Cannula for Obstructive Sleep Apnea
A study testing High flow nasal cannula in people with Obstructive Sleep Apnea, run by Chung-Chieh, Yu at 1 site in Taiwan.
Trial summary
This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2017to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea hypopnea index greater than 5 times per hour
- Age greater than 18 years old.
Who cannot join
- Central sleep apnea
- Hypoventilation syndrome
- Chronic obstructive airway disease
- Receive soft palate surgery or used an oral appliance
- Intolerance to transnasal high flow or CPAP
- Pregnant women
- Unstable hemodynamic state
- Eastern Cooperative Oncology Group Performance Status higher than grade 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea
This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.
Read the detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness.
Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy.
All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- High flow nasal cannula
- Keywords
- Continuous Positive Airway pressure, High Flow Nasal Cannula
- 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
Also called continuous positive airway pressure
All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.
| Study group | Role | What they receive |
|---|---|---|
| First night HFNC group | Experimental | The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy. Receives: Device: High flow nasal cannula |
| First night CPAP group | Active comparator | In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy. Receives: Device: High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Measured: 2 days
Oxygen Desaturation Index
The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Measured: 2 days
Secondary outcomes (2)
Total Sleep Time
The total amount of sleep time spent during a study period.
Measured: 2 days
Sleep Efficiency
Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.
Measured: 2days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start30 Dec 2017
- Primary completion30 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Model description
- All of participants will be randomly allocated into two groups as random number table. The first group will ongoing CPAP therapy in first night and high flow nasal cannula in the second night. The second group will oppositely performed high flow nasal cannula in first night and CPAP in second night.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Chieh, Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chung-Chieh, Yu, Chang Gung Memorial Hospital
- Investigators
- Sleep center, Principal investigator, Chang Gung Memorial Hospital, Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843372
- Sponsor's protocol ID
- 201601844B0
- Status last verified
- Nov 2020
- First submitted
- 9 Feb 2019
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participants raw data will be made available.
Publications
Yu CC, Huang CY, Hua CC, Wu HP. High-flow nasal cannula compared with continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2022 Jun;26(2):549-558. doi: 10.1007/s11325-021-02413-0. Epub 2021 Jun 18.
PubMed 34145538
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03843372
- Acronym / sponsor ID
- 201601844B0
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway pressure, High Flow Nasal Cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chung-Chieh, YuUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.
Detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness.
Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy.
All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All of participants will be randomly allocated into two groups as random number table. The first group will ongoing CPAP therapy in first night and high flow nasal cannula in the second night. The second group will oppositely performed high flow nasal cannula in first night and CPAP in second night.
| Arm | Type | Receives |
|---|---|---|
| First night HFNC group | Experimental | Device: High flow nasal cannulaThe first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy. |
| First night CPAP group | Active comparator | Device: High flow nasal cannulaIn contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apnea hypopnea index greater than 5 times per hour
- Age greater than 18 years old.
Key exclusion criteria (8 listed)
- Central sleep apnea
- Hypoventilation syndrome
- Chronic obstructive airway disease
- Receive soft palate surgery or used an oral appliance
- Intolerance to transnasal high flow or CPAP
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 cannulaAlso: continuous positive airway pressureAll of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure. | Device | First night CPAP group, First night HFNC group |
Primary outcome
Apnea Hypopnea Index
Time frame: 2 days
The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Oxygen Desaturation Index
Time frame: 2 days
The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
2 secondary outcomes
Total Sleep Time
Time frame: 2 days
Sleep Efficiency
Time frame: 2days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34145538Yu CC, Huang CY, Hua CC, Wu HP. High-flow nasal cannula compared with continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2022 Jun;26(2):549-558. doi: 10.1007/s11325-021-02413-0. Epub 2021 Jun 18.
- Individual participant dataSharing planned: Yes. De-identified participants raw data will be made available.
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The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
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A Study of the Sleepnet Elara APAP Device
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Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
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.
Sleep center principal investigator
Chang Gung Memorial Hospital, Keelung
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 in people with Obstructive Sleep Apnea, run by Chung-Chieh, Yu at 1 site in Taiwan.
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 2 inclusion and 8 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 17 Dec 2020. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Apnea Hypopnea Index (time frame: 2 days). The study lists 2 primary outcomes in all. 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 NCT03843372, 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 17 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.