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临床试验/NCT03843372
NCT03843372
已完成
不适用

High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea

Chung-Chieh, Yu1 个研究点 分布在 1 个国家目标入组 32 人2017年12月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Obstructive Sleep Apnea
发起方
Chung-Chieh, Yu
入组人数
32
试验地点
1
主要终点
Apnea Hypopnea Index
状态
已完成
最后更新
5年前

概览

简要总结

This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.

详细描述

Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness. Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy. All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.

注册库
clinicaltrials.gov
开始日期
2017年12月30日
结束日期
2020年3月30日
最后更新
5年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Chung-Chieh, Yu
责任方
Sponsor Investigator
主要研究者

Chung-Chieh, Yu

Director of Sleep Center

Chang Gung Memorial Hospital

入排标准

入选标准

  • Apnea hypopnea index greater than 5 times per hour
  • Age greater than 18 years old.

排除标准

  • Central sleep apnea
  • Hypoventilation syndrome
  • Chronic obstructive airway disease
  • Receive soft palate surgery or used an oral appliance
  • Intolerance to transnasal high flow or CPAP
  • Pregnant women
  • Unstable hemodynamic state
  • Eastern Cooperative Oncology Group Performance Status higher than grade 2

结局指标

主要结局

Apnea Hypopnea Index

时间窗: 2 days

The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.

Oxygen Desaturation Index

时间窗: 2 days

The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.

次要结局

  • Sleep Efficiency(2days)
  • Total Sleep Time(2 days)

研究点 (1)

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