AutoSet for Her Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 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
研究组 & 干预措施
Unblinded Investigational Arm
Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
干预措施: Modified AutoSet algorithm (Device)
Standard AutoSet algorithm
Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
干预措施: Standard AutoSet algorithm (Device)
Standard AutoSet algorithm
Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
干预措施: Modified AutoSet algorithm (Device)
Modified AutoSet algorithm
Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
干预措施: Standard AutoSet algorithm (Device)
Modified AutoSet algorithm
Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
干预措施: Modified AutoSet algorithm (Device)
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)