NCT03372070撤回不适用
Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- change in snoring duration
研究概览
简要总结
The aim of this pilot study is to gain information on the ability of a continuous negative external pressure collar to safely reduce snoring in primary snorers, and if so to determine whether the reduction in snoring has benefits for both the snorer and the bed partner. This clinical trial will involve both the snorer and his or her bed partner, both of whom must qualify and provide informed consent for participation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •if a previously done polysomnogram (PSG) is available, AHI<5
- •snoring identified by a previous PSG and/or by the bed partner
- •Key bed partner Inclusion criteria
- •must have regularly slept with the snorer over the previous month and must plan to sleep with the snorer for the duration of the trial
- •considers that the snorer's snoring is a problem
- •must discontinue use of any snore-masking equipment or ear plug for at least two weeks prior to the initial visit to the study site and agree to refrain from their use for the duration of the trial
- •Key snorer exclusion criteria:
- •sleep disturbance other than snoring
- •snoring due primarily to abnormality of the nasopharynx
- •use of snoring treatment during the month prior to the initial visit
- •neck anatomic or skin abnormalities
- •serious medical condition
- •excessive drug or alcohol intake
- •Key bed partner exclusion criteria:
- •known sleep disorder
排除标准
- 未提供
研究组 & 干预措施
cNEP
Experimental
silicone collar applied to anterior neck
干预措施: cNEP (Device)
结局指标
主要结局
change in snoring duration
时间窗: two weeks after initiation of treatment
duration of snoring as a percent of total sleep time compared to baseline
次要结局
- change in apnea-hypopnea index (AHI)(two weeks after initiation of treatment)
- change in snoring intensity(two weeks after initiation of treatment)
- Treatment-emergent adverse events(two weeks)
- change in Epworth Sleepiness Scale (ESS)(two weeks after initiation of treatment)
- Short Form Survey 36 (SF-36)(one week time frame, administered two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scale: Snorer's sleep(previous week, assessed one and two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scale: Bed partner's complaints about snoring(previous week, assessed one and two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scale: Acceptability of cNEP("overall experience to date", assessed one and two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scale: Bed partner's impression of snorer's sleep(previous week, assessed one and two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scales: bed partner's sleep(previous week, assessed one and two weeks after initiation of treatment)
- Clinical Global Impression (CGI) Scale: Bed partner's overall relationship with snorer(previous week, assessed one and two weeks after initiation of treatment)
研究者
研究点 (2)
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