ISRCTN59353477已完成不适用
Treatment by uninterrupted positive airway pressure by nasal route - Evaluation of REMstar® Auto with C-Flex in clinical practice
Respironics International (France)0 个研究点目标入组 20 人开始时间: 2008年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- Male
入选标准
- •1. Male adults >18
- •2. Index of apnoea/ hypopnoeas >30/hour
- •3. Able to provide written consent
排除标准
- •1. Past experience of treatment with positive airway pressure or non invasive ventilation
- •2. Participants who require 2 levels of pressure for nocturnal alveolar hypoventilation linked to a co-morbidity (obesity, hypoventilation, chronic obstructive pulmonary disease [COPD]) of sleep aponea/ hypopnoea syndrome
- •3. Participants that have undergone surgery for the treatment of sleep apnoea/ hypopnoea syndrome, snore or tumour in the last 6 months or after their polysomnography (PSG) diagnosis
- •4. Tracheostomy
- •5. Respiratory infection, sinusitis or internal ear infection
- •6. Dermatitis or other facial lesions preventing the application of a mask
- •7. Unable to give written informed consent
- •8. Participants unwilling to volunteer
- •9. Unstable medication
- •10. Participants presenting with clinically significant COPD or unstable cardiac insufficiency
- •11. People benefiting from a reinforced protection will not be included in this study. This refers to subjects protected by law, persons accepted in a health or social establishment, private individuals of freedom by a court or administrative order, ill in urgent situation, and persons hospitalised without consent.
- •12. Participants should not have participated in a trial in the 3 months preceding or following the study
研究者
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