Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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

Official Title
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Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation

Intervention / Treatment
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* Device: CPAP
* Device: high-flow nasal canula oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are divided into 2 groups:HFNC group and CPAP group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP group<br>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. | Device: CPAP<br>* At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，<br>|
| Experimental: HFNC group<br>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. | Device: high-flow nasal canula oxygen therapy<br>* At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI | The data of the patient's AHI will be collected to evaluate the change of the patient's sleep. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months. | 
| Gender | general condition | by experiment finished:about 1 year | 
| age | general condition | by experiment finished:about 1 year | 
| height | general condition | by experiment finished:about 1 year | 
| weight | general condition | by experiment finished:about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time | The data will be collected to evaluate the change of the patient's sleep. | 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. | 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. | 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. | 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. | 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. | 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. | 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.. | Change from Baseline blood pressure data at 1 month and 6 months. |