Sleep and Breathing in Health and Disease (Part 2A - Chemical Stimuli, Sleep and Breathing in the General Population)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The Central Apnea-hypopnea Index
研究概览
简要总结
Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus of this proposal is to identify the role of the physiologic path involving cortical arousals in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study will shed light on the mechanisms underlying CSA that involve cortical arousals and will guide future therapeutic interventions for CSA.
详细描述
The literature suggests that zolpidem may be effective in the treatment of central sleep apnea (CSA). However, evidence regarding the efficacy of zolpidem and the underlying mechanisms involved in its effect on CSA are not well-studied. Furthermore, respiratory-related arousals are hypothesized to contribute CSA symptoms and severity. The aim of the study is to determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of the nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related arousals, lower the central apnea-hypopnea index, and widen the CO2 reserve during sleep in patients with CSA compared to no treatment. Participants will complete a night study on a low dose of zolpidem and another night study without zolpidem in a crossover manner. The order of night studies is randomized. The results will help unveil the role of arousals in CSA and the acute effect of zolpidem on CSA severity and the propensity to CSA.
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
- Single (Outcomes Assessor)
盲法说明
Personnel conducting assessment of outcomes and data analysis are blinded to treatment.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.
排除标准
- •less than 18 years old
- •pregnant or breastfeeding female
- •have severe respiratory disease that require to be on oxygen
- •recent health event that may affect the ability to participate in the study,
- •Body Mass Index (BMI) is >40 kg/m2
- •significant insomnia
- •mental instability
- •recent health event that may affect sleep
- •if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study
研究组 & 干预措施
Zolpidem, then No Treatment
Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.
干预措施: Zolpidem (Drug)
Zolpidem, then No Treatment
Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.
干预措施: No Treatment (Other)
No Treatment, then Zolpidem
Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
干预措施: Zolpidem (Drug)
No Treatment, then Zolpidem
Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
干预措施: No Treatment (Other)
结局指标
主要结局
The Central Apnea-hypopnea Index
时间窗: one night
The number of central apneas and hypopneas per hour of sleep was obtained from polysomnography studies.
Respiratory Arousal Index
时间窗: one night
A measure of the frequency of respiratory-related arousals during sleep
次要结局
- Controller Gain(one night)
- Stead-State Plant Gain (mmHg(one night)
- CO2 Reserve(one night)
- Respiratory Arousal Threshold(one night)
研究者
M Safwan Badr
Chair of Internal Medicine
Wayne State University