An Initial Investigation of the Safety and Tolerability of Transcutaneous Stimulation of the Hypoglossal Nerve for the Treatment of Primary Snoring and Mild Sleep Apnea Using the ZENS Transcutaneous Nerve Stimulator (PLUTO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Percent change in loud snoring time
研究概览
简要总结
The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).
详细描述
After indicating their consent to contact and signing an Informed Consent Form, potential participants will undergo a screening assessment that includes a review of their medical history, a focused physical exam, and a level 3 at-home sleep test (Sagatech SnoreSat Sleep Recorder, Philips Alice OneNight or equivalent), if not already available in the medical records). At the screening visit potential participants' eligibility for the study will be evaluated against the study inclusion and exclusion criteria.
Following confirmation of eligibility, up to 45 (n=45) participants will be scheduled for their overnight in-laboratory PSG, which must occur no more than 12 weeks after screening has taken place. A final determination of eligibility and "enrollment" is completed when inclusion and exclusion criteria are verified on the day of the study visit. Those who do not meet inclusion and exclusion criteria on the day of the study will be deemed "screening failures".
Participants will wear the ZENS Device for the 8 to 12-hour overnight in-laboratory polysomnography assessment. Participants will be monitored for and asked about any adverse events and device effects that they experience during the overnight sleep study.
Participants will be contacted by the site via telephone 24 to 96 hours after the overnight sleep study to determine if any adverse events and device effects were experienced late after the overnight polysomnography. After the telephone follow-up, participation in the study is complete.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent change in loud snoring time
时间窗: up to 5 hours
The percentage change in snoring time in the "ON" versus "OFF" period
次要结局
- Number of patients with successful snoring reduction(up to 5 hours)
- Percentage difference of time (minutes) per hour of sleep with loud snoring(up to 5 hours)
- Change in AHI(up to 5 hours)
- Change in the number of arousals and awakenings in the "ON" versus "OFF" phase(up to 5 hours)
- Difference in the mean oxygen saturation levels(up to 5 hours)