Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index [AHI]
研究概览
简要总结
Currently, there is no pharmacological intervention for OSA that targets multiple pathophysiological deficits in combination. Here the investigators study the effect on sleep apnea severity of combinations of pharmacological agents that stimulate the pharyngeal muscles, stabilize ventilatory control, and increase the arousal threshold.
详细描述
The primary goal of the current study is to determine the effect of combination therapy targeting phenotypic traits on OSA severity. Specifically, the investigators will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index and the arousal index (co-primary outcome variables).
The investigators will also estimate the effects of the interventions on the physiological traits responsible for OSA using polysomnography, namely:
- Pharyngeal anatomy and its propensity towards collapse
- The ability of the upper airway dilator muscles to activate and reopen the airway during sleep (i.e. neuromuscular compensation)
- Arousal threshold from sleep (i.e. the propensity for hypopneas/apneas to lead to arousal and fragmented sleep).
- Stability of the ventilatory control system feedback loop (i.e. loop gain). Baseline traits will be used to examine whether patient characteristics influence the responses to each combination of interventions (i.e. muscles, muscles plus loop gain, muscles plus arousal threshold).
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
SAS0421a, SAS0421b and SAS0421c
Participants will take SAS0421a, SAS0421b and SAS0421c for 3 days. Half doses will be given on the first night.
干预措施: SAS0421b (Drug)
SAS0421a, SAS0421b and SAS0421c
Participants will take SAS0421a, SAS0421b and SAS0421c for 3 days. Half doses will be given on the first night.
干预措施: SAS0421a (Drug)
SAS0421a, SAS0421b and SAS0421c
Participants will take SAS0421a, SAS0421b and SAS0421c for 3 days. Half doses will be given on the first night.
干预措施: SAS0421c (Drug)
SAS0421a and SAS0421b
Participants will take SAS0421a and SAS0421b for 3 days. Half doses will be given on the first night.
干预措施: SAS0421a (Drug)
SAS0421a and SAS0421b
Participants will take SAS0421a and SAS0421b for 3 days. Half doses will be given on the first night.
干预措施: SAS0421b (Drug)
SAS0421c
Participants will take SAS0421c for 3 days. Half doses will be given on the first night.
干预措施: SAS0421c (Drug)
Placebo
Participants will take placebos for 3 days.
干预措施: placebo (Drug)
结局指标
主要结局
Apnea-hypopnea index [AHI]
时间窗: 3 days
Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline
次要结局
- Arousal Index(3 days)
- Hypoxic Burden(3 days)
- Visual Analog Scale for Sleep Quality(3 days)
- Visual Analog Scale for Waking Unrefreshed(3 days)
研究者
Scott Aaron Sands
Assistant Professor of Medicine
Brigham and Women's Hospital