RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- longest apnea time
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 Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.
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
- Single (Outcomes Assessor)
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
- •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.
排除标准
- •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
longest apnea time
时间窗: The fourth day of enrollment
Maximum duration(s) of nocturnal sleep apnea in patients
AHI
时间窗: The fourth day of enrollment
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Treatment failure rate
时间窗: The fourth day of enrollment
Number of patients unable to tolerate treatment/enrollment
Good compliance rate
时间窗: The fourth day of enrollment
Number of patients treated for more than 4 hours per night/enrolled
minimum oxygen saturation
时间窗: The fourth day of enrollment
Lowest oxygen saturation during the patient's night sleep
Mean oxygen saturation
时间窗: The fourth day of enrollment
Mean oxygen saturation during the patient's night sleep
次要结局
- age(The first day of enrollment)
- total sleep time(The fourth day of enrollment)
- Number of awakening(The fourth day of enrollment)
- height(The first day of enrollment)
- Gender(The first day of enrollment)
- weight(The first day of enrollment)