Impact of Acetazolamide on Central Sleep Apnea Patients Receiving Medication for Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Central Apnea Index (CAI)
研究概览
简要总结
Patients with opioid use disorder treated with either methadone or buprenorphine are at risk of developing central sleep apnea (CSA) from these medications. Investigators will conduct a mechanistic trial using acetazolamide, a medicine known to improve CSA in other settings, to determine if acetazolamide can improve CSA due to medication for opioid use disorder and whether this leads to physiologic changes that might lead to reduced drug craving. Patients treated with medication for opioid use disorder and who have central sleep apnea will be randomized to treatment with acetazolamide or matching placebo for 7 days. At the end of the 7 days, they will undergo an overnight sleep study to assess the impact on breathing during sleep as well as sleep quality. In addition, measures of sympathetic tone, anxiety, arousal, cognition, and drug craving will be measured to determine if treatment of CSA with acetazolamide can produce physiologic changes that might contribute to improved health.
详细描述
Medications used to treat opioid use disorder (MOUD) such as methadone and buprenorphine have been found to cause central sleep apnea (CSA), but the clinical ramifications are unclear. It has been hypothesized that the sleep fragmentation and intermittent hypoxemia caused by CSA from MOUD may lead to sympathetic activation, nocturnal arousal, increased anxiety, and cognitive impairment that may in turn increase drug craving and drug relapse. This mechanistic study will evaluate the potential adverse effect of CSA in patients on MOUD by evaluating the impact of acetazolamide to improve CSA and thereby lead to downstream physiologic changes in measures of sleep quality, sympathetic tone, nocturnal arousal, anxiety, cognitive functioning, and drug craving.
Eligible individuals will undergo an overnight research visit including overnight polysomnography, assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive testing, and drug craving. Individuals with opioid-induced CSA will be randomized into a parallel-arm trial of acetazolamide vs. placebo with overnight research visit for outcome assessment at 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo pill matched to look like active drug.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on Medication for Opioid Use Disorder (MOUD) with central sleep apnea.
排除标准
- •Sleep-related Hypoventilation.
- •Other causes of Central Sleep Apnea besides Opioid Use.
- •Pregnancy.
- •Contraindications for Acetazolamide.
研究组 & 干预措施
Acetazolamide
All participants in this group will receive one acetazolamide 250 mg pill in the evening for 7 days.
干预措施: Acetazolamide (Drug)
Placebo
All participants in this group will receive one matching placebo pill in the evening for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Central Apnea Index (CAI)
时间窗: 7 days
The number of central apneas per hour of sleep, assessed by overnight polysomnography. * It can range from 0 to undefined events per hour. * Higher values indicate more severe central sleep apnea.
次要结局
- Low frequency / high-frequency ratio (LF/HF ratio)(7 days)
- Apnea Hypopnea Index (AHI)(7 days)
研究者
Sanjay R Patel
Professor
University of Pittsburgh