Obstructive Sleep ApneaNCT05549245
Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea
A study testing high-flow nasal cannula oxygen therapy, and CPAP in people with Obstructive Sleep Apnea, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Patients meeting the criteria of obstructive sleep apnea were included, and all patients signed informed consent, which met the requirements of the ethics Committee of our unit. All subjects were hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- high-flow nasal cannula oxygen therapy, and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2022to May 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- There were typical symptoms of sleep snoring at night with apnea and daytime sleepiness (ESS score ≥9). Stenosis and obstruction in any part of the upper airway were observed on physical examination, with AHI≥5 times /h.
- For patients with no significant daytime sleepiness (ESS score < 9), AHI≥10 times /h.
- Patients with AHI≥5 times /h had one or more OSAHS complications, such as cognitive impairment, hypertension, coronary heart disease, cerebrovascular disease, diabetes and insomnia.
Who cannot join
- Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy.
- Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc.
- Hemodynamic instability.
- Severe respiratory diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Dedong Ma, Doctor, 18560082806, ma@qiluhuxi.com
Enqi Zhao, doctor, 15550834269, zeq@qiluhuxi.com
About this study
Official title: RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea
Patients meeting the criteria of obstructive sleep apnea were included, and all patients signed informed consent, which met the requirements of the ethics Committee of our unit. All subjects were hospitalized patients. Subjects were randomly enrolled into High-flow Nasal Cannula Oxygen Therapy group or Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- high-flow nasal cannula oxygen therapy,, CPAP
- Keywords
- Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy
- 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 cannula oxygen therapy,Device
Patients were treated with high-flow nasal cannula oxygen therapy for three nights
CPAPDevice
Patients were treated with CPAP for three nights
| Study group | Role | What they receive |
|---|---|---|
| High-flow Nasal Cannula Oxygen Therapy group | Experimental | Not described Receives: Device: high-flow nasal cannula oxygen therapy, |
| Continues Positive Airway Pressure group | Other | Not described Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Measured: The first day of enrollment
AHI
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Measured: The fourth day of enrollment
Treatment failure rate
Number of patients unable to tolerate treatment/enrollment
Measured: The fourth day of enrollment
Good compliance rate
Number of patients treated for more than 4 hours per night/enrolled
Measured: The fourth day of enrollment
longest apnea time
Maximum duration(s) of nocturnal sleep apnea in patients
Measured: The first day of enrollment
longest apnea time
Maximum duration(s) of nocturnal sleep apnea in patients
Measured: The fourth day of enrollment
Mean oxygen saturation
Mean oxygen saturation during the patient's night sleep
Measured: The first day of enrollment
Mean oxygen saturation
Mean oxygen saturation during the patient's night sleep
Measured: The fourth day of enrollment
minimum oxygen saturation
Lowest oxygen saturation during the patient's night sleep
Measured: The first day of enrollment
minimum oxygen saturation
Lowest oxygen saturation during the patient's night sleep
Measured: The fourth day of enrollment
Secondary outcomes (8)
Gender
Male and female
Measured: The first day of enrollment
height
Height (in cm)
Measured: The first day of enrollment
age
years
Measured: The first day of enrollment
weight
Kg
Measured: The first day of enrollment
total sleep time
Total sleep duration(min) of the patient at night
Measured: The first day of enrollment
total sleep time
Total sleep duration(min) of the patient at night
Measured: The fourth day of enrollment
Number of awakening
The number of awakenings during the patient's night sleep
Measured: The first day of enrollment
Number of awakening
The number of awakenings during the patient's night sleep
Measured: The fourth day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Aug 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Qilu Hospital of Shandong UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- enqi Zhao, master, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549245
- Sponsor's protocol ID
- 2022038
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
PubMed 23910433Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
PubMed 31300334Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19.
PubMed 23513246Nakanishi N, Suzuki Y, Ishihara M, Ueno Y, Tane N, Tsunano Y, Itagaki T, Oto J. Effect of High-Flow Nasal Cannula on Sleep-disordered Breathing and Sleep Quality in Patients With Acute Stroke. Cureus. 2020 Jul 20;12(7):e9303. doi: 10.7759/cureus.9303.
PubMed 32832300Yan H, Qinghua L, Mengyuan P, Yaoyu C, Long Z, Mengjie L, Xiaosong D, Fang H. High flow nasal cannula therapy for obstructive sleep apnea in adults. Sleep Breath. 2022 Jun;26(2):783-791. doi: 10.1007/s11325-021-02453-6. Epub 2021 Aug 12.
PubMed 34383275Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1.
PubMed 19952061
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05549245
- Acronym / sponsor ID
- 2022038
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 22 Sep 2022 (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.
Patients meeting the criteria of obstructive sleep apnea were included, and all patients signed informed consent, which met the requirements of the ethics Committee of our unit. All subjects were hospitalized patients. Subjects were randomly enrolled into High-flow Nasal Cannula Oxygen Therapy group or Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow Nasal Cannula Oxygen Therapy group | Experimental | Device: high-flow nasal cannula oxygen therapy, |
| Continues Positive Airway Pressure group | Other | Device: CPAP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- There were typical symptoms of sleep snoring at night with apnea and daytime sleepiness (ESS score ≥9). Stenosis and obstruction in any part of the upper airway were observed on physical examination, with AHI≥5 times /h.
- For patients with no significant daytime sleepiness (ESS score < 9), AHI≥10 times /h.
- Patients with AHI≥5 times /h had one or more OSAHS complications, such as cognitive impairment, hypertension, coronary heart disease, cerebrovascular disease, diabetes and insomnia.
Key exclusion criteria (4 listed)
- Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy.
- Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc.
- Hemodynamic instability.
- Severe respiratory diseases.
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 cannula oxygen therapy,Patients were treated with high-flow nasal cannula oxygen therapy for three nights | Device | High-flow Nasal Cannula Oxygen Therapy group |
| CPAPPatients were treated with CPAP for three nights | Device | Continues Positive Airway Pressure group |
Primary outcome
AHI
Time frame: The first day of enrollment
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
AHI
Time frame: The fourth day of enrollment
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Treatment failure rate
Time frame: The fourth day of enrollment
Number of patients unable to tolerate treatment/enrollment
Good compliance rate
Time frame: The fourth day of enrollment
Number of patients treated for more than 4 hours per night/enrolled
longest apnea time
Time frame: The first day of enrollment
Maximum duration(s) of nocturnal sleep apnea in patients
longest apnea time
Time frame: The fourth day of enrollment
Maximum duration(s) of nocturnal sleep apnea in patients
Mean oxygen saturation
Time frame: The first day of enrollment
Mean oxygen saturation during the patient's night sleep
Mean oxygen saturation
Time frame: The fourth day of enrollment
Mean oxygen saturation during the patient's night sleep
minimum oxygen saturation
Time frame: The first day of enrollment
Lowest oxygen saturation during the patient's night sleep
minimum oxygen saturation
Time frame: The fourth day of enrollment
Lowest oxygen saturation during the patient's night sleep
8 secondary outcomes
Gender
Time frame: The first day of enrollment
height
Time frame: The first day of enrollment
age
Time frame: The first day of enrollment
weight
Time frame: The first day of enrollment
total sleep time
Time frame: The first day of enrollment
total sleep time
Time frame: The fourth day of enrollment
Number of awakening
Time frame: The first day of enrollment
Number of awakening
Time frame: The fourth day of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 23910433Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
- Background: PubMed 31300334Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
- Background: PubMed 23513246Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19.
- Background: PubMed 32832300Nakanishi N, Suzuki Y, Ishihara M, Ueno Y, Tane N, Tsunano Y, Itagaki T, Oto J. Effect of High-Flow Nasal Cannula on Sleep-disordered Breathing and Sleep Quality in Patients With Acute Stroke. Cureus. 2020 Jul 20;12(7):e9303. doi: 10.7759/cureus.9303.
- Background: PubMed 34383275Yan H, Qinghua L, Mengyuan P, Yaoyu C, Long Z, Mengjie L, Xiaosong D, Fang H. High flow nasal cannula therapy for obstructive sleep apnea in adults. Sleep Breath. 2022 Jun;26(2):783-791. doi: 10.1007/s11325-021-02453-6. Epub 2021 Aug 12.
- Background: PubMed 19952061Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1.
- 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.
enqi Zhao, master principal investigator
Qilu Hospital of Shandong University
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 oxygen therapy, and CPAP in people with Obstructive Sleep Apnea, run by Qilu Hospital of Shandong University at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dedong Ma, doctor (18560082806, ma@qiluhuxi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI (time frame: The first day of enrollment). The study lists 10 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 NCT05549245, which also lists 6 linked publications.
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 22 Sep 2022.