NCT01826513已完成不适用
AutoSet for Her Clinical Trial Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Apnoea Hypopnoea Index (AHI)
研究概览
简要总结
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.
Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.
User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal females aged ≥ 18 years
- •Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry
- •Diagnostic PSG available
- •Diagnosis of mild-moderate OSA (AHI ≤ 30)
- •Participants willing and able to give written informed consent
排除标准
- •Participants currently using Bi-level PAP
- •Participants currently using supplemental oxygen
- •Participants who are pregnant
- •Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
- •Participants who the researcher believes are unsuitable for inclusion because either:
- •they do not comprehend English
- •they are unable to provide written informed consent
- •they are physically unable to comply with the protocol
结局指标
主要结局
Apnoea Hypopnoea Index (AHI)
时间窗: 1 day
Number of apnoeas and hypopnoeas per hour of sleep
Oxygen Desaturation Index (ODI)
时间窗: 1 day
Number of oxygen desaturations per hour of sleep
次要结局
- Wake After Sleep Onset Time(1 day)
- Sleep Efficacy(1 day)
- Number of Hypopnoeas(1 day)
- Time Taken to Fall Asleep(1 day)
- Number of Central Apnoeas(1 day)
- Percentage of Total Sleep Time Spent in Each Sleep Stage(1 day)
- Number of Respiratory Event Related Arousals(1 day)
- Number of Spontaneous Arousals(1 day)
- Number of Obstructive Apnoeas(1 day)
- Oxygen Saturation(1 day)
研究者
研究点 (2)
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