Validation of Safety and Efficacy for Night Shift Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
研究概览
简要总结
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
详细描述
The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Neck, back or should pain which would impact ability to sleep laterally each night
- •Body mass index > 35
- •suffering from neurological disorders which result in ticks or tremors
- •diagnosed with congestive heart failure or chronic obstructive pulmonary disease
- •suffered from a stroke within the previous 12 months
- •taking or planning to take narcotic medications
- •unfamiliar with use of internet browsers
- •travel (i.e., foreign or cruise ship) which would limit internet or mail access
- •planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications
结局指标
主要结局
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
时间窗: Four weeks
Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.
Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy
时间窗: 30-days
Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.
次要结局
- Confirmation That Night Shift Accurately Detects Supine Position(baseline and 4-weeks later at follow up)
- Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant(four weeks)
- Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback(four weeks)
- Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA(baseline and followup)
- Evaluate Impact of Positional Therapy on Quality of Life Scores(four weeks)
- Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake(baseline and follow-up)
- Assess the Accuracy of Night Shift's Measurement of Total Sleep Time(one night)
- Assess the Accuracy of Night Shift Measurement of Sleep Efficiency(one night)