ISRCTN00260427已完成不适用
TransNasal Insufflation for obstructive sleep apnoea (OSA)
Respironics, Inc. (USA)0 个研究点目标入组 30 人开始时间: 2008年4月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 21 - 65 years, either sex
- •2. Diagnosis of OSA with a baseline AHI between 15 and 50 events/hour of sleep
- •3. Able and willing to provide written informed consent
- •4. English speaking
排除标准
- •1. Participation in another interventional research study within the last 30 days
- •2. Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
- •3. Prior PAP use or treatment for OSA, excluding split-night PAP exposure
- •4. Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCO2 greater than or equal to 55 mmHg)
- •5. Presence of untreated, non-OSA related sleep disorders, e.g., moderate to severe restless legs (Periodic Limb Movement Index [PLMI] greater than or equal to 10) or insomnia
- •6. Body mass index (BMI) greater than 40 kg/m^2. Most subjects will have a BMI less than or equal to 35 kg/m^2 but we will include a small subset of subjects with a BMI greater than 35 kg/m^2 but less than or equal to 40 kg/m^2.
- •7. Severe sleepiness (automobile accident or near accident in the last 12 months due to sleepiness)
- •8. Severe oxygen desaturation on the polysomnography (PSG) (oxygen saturation [Sa02] less than 70% for 10% of the diagnostic PSG study)
- •9. Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
- •10. Currently using supplemental oxygen
- •11. Regular use of sleeping pills or stimulants
- •12. Currently working night shift or rotating day/night shift
- •There will be no exclusion based on gender, race or ethnicity.
研究者
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