Pharmacological Intervention for Symptomatic Snoring
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Snoring intensity
研究概览
简要总结
Currently, there is no pharmacological intervention capable of maintaining airway patency for the treatment of snoring and airflow limitation during sleep. Here we study the effect of pharmacological stimulation of the pharyngeal muscles on snoring severity, in a randomized quadruple-blind, crossover study.
详细描述
Two active interventions are being studied and compared against placebo. Participants will therefore be randomized to one of six possible sequences. Washout periods will be 1 week.
Effects of interventions on outcomes will be assessed using mixed effect model analyses: we will quantify the effect of active treatment 1 (referenced to placebo), the effect of active treatment 2 (referenced to placebo), adjusting for effects of time (period number), carryover effects, and baseline values (fixed effects). Participants are considered random effects.
Primary outcome is based on significance of active intervention 1 versus placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 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
- 未提供
研究组 & 干预措施
Active H
Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
干预措施: SAS2094AH and SAS2094BH (Drug)
Active L
Participants will take SAS2094AL and SAS2094BL for 10 days
干预措施: SAS2094AL and SAS2094BL (Drug)
Placebo
Participants will take placebo for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Snoring intensity
时间窗: 1 week
mean tracheal snoring sound intensity (tracheal microphone), decibels
次要结局
- Stage 1 Sleep(1 week)
- Arousal index(1 week)
- Visual-Analog Scale for Treatment Satisfaction(1 week)
- Epworth Sleepiness Scale(1 week)
- Visual-Analog Scale for Sleep Quality(1 week)
- Flow-limitation severity(1 week)
- Mean oxygen saturation(1 week)
- Snoring frequency(1 week)
- Snoring Self-Evaluation Scale(1 week)
- Snoring Bed-Partner Evaluation Scale(1 week)
- Flow-limitation frequency(1 week)
- Functional Outcomes of Sleep Questionnaire(1 week)
- "Would you keep using this medication?"(1 week)
研究者
Scott Aaron Sands
Assistant Professor of Medicine
Brigham and Women's Hospital