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临床试验/NCT05475119
NCT05475119Unknown不适用

Effect of High Flow Nasal Cannula (HFNC) Versus Continues Positive Airway Pressure (CPAP) in Adults With Obstructive Sleep Apnea

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Sleep architecture while using High Flow Nasal Cannula oxygen device

研究概览

简要总结

The participants whom undergo Polysomnography study (Sleep study) and are found to have mild, moderate or severe Obstructive Sleep Apnea (OSA) will have two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

详细描述

The participants undergo three nights in the Sleep Lab. In their first night they perpetrate Polysomnography study (Sleep study) and then classifies to have mild, moderate or severe Obstructive Sleep Apnea (OSA) or not. Those who are diagnosed with OSA, will undergo two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patient aging above 18 years
  • Diagnosed with Obstructive Sleep Apnea (OSA) based on Polysomnography (PSG) ranging from mild to severe i.e. more than 5

排除标准

  • Patients with hypoventilation syndrome
  • Patients with chronic obstructive pulmonary disease
  • Patients who have unstable hemodynamic state, who experienced intolerance to HFNC or CPAP
  • Patients who are pregnant
  • Patients recently underwent surgery

结局指标

主要结局

Sleep architecture while using High Flow Nasal Cannula oxygen device

时间窗: two nights

Standard sleep architecture: sleep breathing disorder e.g. apnea, hypopnea, snoring Oxygenation : minimum oxygen saturation, duration of desaturation and number of desaturation Arousals : number and index

Apnea/Hypopnea Index count using High Flow Nasal Cannula oxygen device and Continuous Positive Pressure Airway device on patients with Obstructive Sleep Apnea

时间窗: two nights

the Apnea/Hypopnea Index (AHI) is 5 events or less

Tolerance and acceptability of High Flow Nasal Cannula by patients compared to the standard Continuous Positive Airway Pressure

时间窗: two nights

Comparison of High Flow Nasal Cannula device compared to the Continuous Positive Airway Pressure for a long term usage; being assessed in 1. How well did you accept the device yesterday? 2. How comfortable was the usage of the device? 3. Was the used mask comfortable? (1)not acceptable, (2)tolerable, (3)acceptable, (4)well received, (5)excellent 4. Did you face any difficulties breathing through your nose while using the device last night? 5. Did you have any of these symptoms while using the mask last night? Nasal dryness, Mouth dryness, Runny nose, Fear or anxiety, Congested nose 6. Did you feel any air leakage from the mask last night ? 7. Was it hard keeping the mask on while sleeping? 8. Are you prepared to use the CPAP machine as a therapy daily?

次要结局

  • Changes in sleep structure compared to the diagnostic night(two night)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siraj Omar Wali

Director of Sleep Medicine and Research Center, Professor of Medicine

King Abdulaziz University

研究点 (1)

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