Obstructive Sleep ApneaHFNCNCT05549310
Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
A study testing CPAP and high-flow nasal canula oxygen therapy in people with Obstructive Sleep Apnea and High Flow Nasal Canula, 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, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation
- What is being tested?
- CPAP and high-flow nasal canula oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to May 2025
- 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
- meet any one of these
- 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; ③ 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
- meet any one of these
- 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
Zhuo Han, Master, 17860623815, 1783498197@qq.com
About this study
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 Continuos Positive Airway Pressure group for 1 month of treatment. Sleep respiration monitoring data including AHI, blood oxygen saturation decline index (ODI) and minimum blood oxygen saturation were recorded before and after treatment.
After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continue to receive corresponding treatment for 6 months.Before and after the study, sleep respiratory monitoring datas,treatment failure rate，good compliance rate are recorded.
Read the detailed description
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 Continuos Positive Airway Pressure group.
Procedure
- The first stage ( RCT study ) : subjects were divided into HFNC group and CPAP group, HFNC group received HFNC treatment 6 hours / night, 1 month ; CPAP group : receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. Patients receiving CPAP treatment were enrolled in the study. Pressure titration was used first, and appropriate pressure was selected before treatment. The initial gas flow rate of patients receiving HFNC treatment was set to 30 - 40 L / min, and FiO2 was titrated to maintain the pulse oxygen saturation above 92 %, which was adjusted according to the patient 's tolerance and comfort.Record nightly sleep respiratory monitoring data, including 1 sleep characteristics : total sleep time, REM time, NREM time, sleep efficiency ( SE ) ; 2 awakening time, awakening index ( Arl ) ; aHI, average apnea time, longest apnea time ; 4 the cumulative time of average oxygen saturation, minimum oxygen saturation, ODI, and oxygen saturation below 90 % ; 5 heart rate, blood pressure, etc.
- The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continued to receive corresponding treatment for 6 months. Follow-up after each stage of treatment, recording sleep respiratory monitoring data, including the main endpoint : 1 Treatment failure rate 2.treatment compliance
- Conditions
- Obstructive Sleep Apnea, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation
- Being tested
- CPAP, high-flow nasal canula 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.
CPAPDevice
At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，
high-flow nasal canula oxygen therapyDevice
At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Active comparator | CPAP group : The first stage:receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment.
The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. CPAP group continued to receive corresponding treatment for 6 months. Receives: Device: CPAP |
| HFNC group | Experimental | HFNC group : The first stage:receiving HFNC treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment.
The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group continued to receive corresponding treatment for 6 months. Receives: Device: high-flow nasal canula oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline AHI data at 1 month and 6 months.
Treatment failure rate
The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
Measured: about sixth month
Good compliance rate
refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
Measured: about sixth month
mean apnea time
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline mean apnea time data at 1 month and 6 months.
longest apnea time
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline longest apnea time data at 1 month and 6 months.
Mean oxygen saturation
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.
Measured: Change from Baseline Mean oxygen saturation data at 1 month and 6 months.
minimum oxygen saturation
The data will be collected to evaluate the change of the patient's oxygen saturation.
Measured: Change from Baseline minimum oxygen saturation data at 1 month and 6 months.
ODI
The data will be collected to evaluate the change of the patient's oxygen saturation.
Measured: Change from Baseline ODI data at 1 month and 6 months.
oxygen saturation < 90 % cumulative timesaturation
The data will be collected to evaluate the change of the patient's oxygen saturation.
Measured: Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.
Gender
general condition
Measured: by experiment finished:about 1 year
age
general condition
Measured: by experiment finished:about 1 year
height
general condition
Measured: by experiment finished:about 1 year
weight
general condition
Measured: by experiment finished:about 1 year
Secondary outcomes (8)
total sleep time
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline total sleep time data at 1 month and 6 months.
REM time
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline REM time data at 1 month and 6 months.
NREM time
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline NREM time data at 1 month and 6 months.
sleep efficiency ( SE )
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.
awakening time
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline awakening time data at 1 month and 6 months.
awakening index ( Arl )
The data will be collected to evaluate the change of the patient's sleep.
Measured: Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.
heart rate
The data will be collected to evaluate the change of the patient's circulation condition.
Measured: Change from Baseline heart rate data at 1 month and 6 months.
blood pressure
The data will be collected to evaluate the change of the patient's circulation condition..
Measured: Change from Baseline blood pressure data at 1 month and 6 months.
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 start22 Aug 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (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
- Model description
- Subjects are divided into 2 groups:HFNC group and CPAP group
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhuo Han, master, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549310
- Sponsor's protocol ID
- 2022037
- Acronym
- HFNC
- Status last verified
- Jul 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 32832300Nilius 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 19952061Yan 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 34383275
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
- Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05549310
- Acronym / sponsor ID
- HFNC / 2022037
- Conditions
- Obstructive Sleep Apnea, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (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 Continuos Positive Airway Pressure group for 1 month of treatment. Sleep respiration monitoring data including AHI, blood oxygen saturation decline index (ODI) and minimum blood oxygen saturation were recorded before and after treatment.
After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continue to receive corresponding treatment for 6 months.Before and after the study, sleep respiratory monitoring datas,treatment failure rate，good compliance rate are recorded.
Detailed description
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 Continuos Positive Airway Pressure group.
Procedure
- The first stage ( RCT study ) : subjects were divided into HFNC group and CPAP group, HFNC group received HFNC treatment 6 hours / night, 1 month ; CPAP group : receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. Patients receiving CPAP treatment were enrolled in the study. Pressure titration was used first, and appropriate pressure was selected before treatment. The initial gas flow rate of patients receiving HFNC treatment was set to 30 - 40 L / min, and FiO2 was titrated to maintain the pulse oxygen saturation above 92 %, which was adjusted according to the patient 's tolerance and comfort.Record nightly sleep respiratory monitoring data, including 1 sleep characteristics : total sleep time, REM time, NREM time, sleep efficiency ( SE ) ; 2 awakening time, awakening index ( Arl ) ; aHI, average apnea time, longest apnea time ; 4 the cumulative time of average oxygen saturation, minimum oxygen saturation, ODI, and oxygen saturation below 90 % ; 5 heart rate, blood pressure, etc.
- The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continued to receive corresponding treatment for 6 months. Follow-up after each stage of treatment, recording sleep respiratory monitoring data, including the main endpoint : 1 Treatment failure rate 2.treatment compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects are divided into 2 groups:HFNC group and CPAP group
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Active comparator | Device: CPAPCPAP group : The first stage:receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. CPAP group continued to receive corresponding treatment for 6 months. |
| HFNC group | Experimental | Device: high-flow nasal canula oxygen therapyHFNC group : The first stage:receiving HFNC treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group continued to receive corresponding treatment for 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet any one of these
- 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.
Key exclusion criteria (5 listed)
- meet any one of these
- 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 |
|---|---|---|
| CPAPAt the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration， | Device | CPAP group |
| high-flow nasal canula oxygen therapyAt the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration， | Device | HFNC group |
Primary outcome
AHI
Time frame: Change from Baseline AHI data at 1 month and 6 months.
The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.
Treatment failure rate
Time frame: about sixth month
The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
Good compliance rate
Time frame: about sixth month
refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
mean apnea time
Time frame: Change from Baseline mean apnea time data at 1 month and 6 months.
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
longest apnea time
Time frame: Change from Baseline longest apnea time data at 1 month and 6 months.
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Mean oxygen saturation
Time frame: Change from Baseline Mean oxygen saturation data at 1 month and 6 months.
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.
minimum oxygen saturation
Time frame: Change from Baseline minimum oxygen saturation data at 1 month and 6 months.
The data will be collected to evaluate the change of the patient's oxygen saturation.
ODI
Time frame: Change from Baseline ODI data at 1 month and 6 months.
The data will be collected to evaluate the change of the patient's oxygen saturation.
oxygen saturation < 90 % cumulative timesaturation
Time frame: Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.
The data will be collected to evaluate the change of the patient's oxygen saturation.
Gender
Time frame: by experiment finished:about 1 year
general condition
age
Time frame: by experiment finished:about 1 year
general condition
height
Time frame: by experiment finished:about 1 year
general condition
weight
Time frame: by experiment finished:about 1 year
general condition
8 secondary outcomes
total sleep time
Time frame: Change from Baseline total sleep time data at 1 month and 6 months.
REM time
Time frame: Change from Baseline REM time data at 1 month and 6 months.
NREM time
Time frame: Change from Baseline NREM time data at 1 month and 6 months.
sleep efficiency ( SE )
Time frame: Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.
awakening time
Time frame: Change from Baseline awakening time data at 1 month and 6 months.
awakening index ( Arl )
Time frame: Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.
heart rate
Time frame: Change from Baseline heart rate data at 1 month and 6 months.
blood pressure
Time frame: Change from Baseline blood pressure data at 1 month and 6 months.
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 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.
- Results publication: 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.
- 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.
Zhuo Han, 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 CPAP and high-flow nasal canula oxygen therapy in people with Obstructive Sleep Apnea and High Flow Nasal Canula, 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 5 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: Change from Baseline AHI data at 1 month and 6 months.). The study lists 13 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 NCT05549310, 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.