Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Treatment failure rate
研究概览
简要总结
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.
详细描述
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. 2. 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
结局指标
主要结局
Treatment failure rate
时间窗: about sixth month
The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
minimum oxygen saturation
时间窗: 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.
longest apnea time
时间窗: 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.
oxygen saturation < 90 % cumulative timesaturation
时间窗: 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.
mean apnea time
时间窗: 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.
Mean oxygen saturation
时间窗: 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.
ODI
时间窗: 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.
age
时间窗: by experiment finished:about 1 year
general condition
height
时间窗: by experiment finished:about 1 year
general condition
AHI
时间窗: 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.
Good compliance rate
时间窗: about sixth month
refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
Gender
时间窗: by experiment finished:about 1 year
general condition
weight
时间窗: by experiment finished:about 1 year
general condition
次要结局
- total sleep time(Change from Baseline total sleep time data at 1 month and 6 months.)
- NREM time(Change from Baseline NREM time data at 1 month and 6 months.)
- REM time(Change from Baseline REM time data at 1 month and 6 months.)
- sleep efficiency ( SE )(Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.)
- blood pressure(Change from Baseline blood pressure data at 1 month and 6 months.)
- awakening time(Change from Baseline awakening time data at 1 month and 6 months.)
- awakening index ( Arl )(Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.)
- heart rate(Change from Baseline heart rate data at 1 month and 6 months.)