Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of times subjects complete CPAP therapy
研究概览
简要总结
The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 - 70 years of age
- •Biological male or female
- •AHI between 15 - 50 events/hour
- •Current or new OSA diagnosis
- •Established or new (within 1 month) CPAP therapy
排除标准
- •BMI > 35 kg/m2
- •Diagnosed psychiatric disorders
- •Hypotension
- •History of seizures
- •History of substance abuse or recreational drug use or positive urine drug screen
- •History of uncontrolled disease including:
- •Cardiovascular
- •Pulmonary
- •Gastrointestinal
- •Pancreatic
- •Hematological
- •Endocrine (including Type I Diabetes)
- •Neurological
- •Urological
- •Pregnant or breastfeeding
- •Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
- •Prescribed CYP2C9 and/or CYP3A4 inhibitors
- •Severe OSA that in the investigator's judgment should only begin CPAP treatment
- •Prior upper airway surgery for snoring or OSA as an adult
- •Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis
- •Bariatric surgery within 2 years
- •Medically managed weight-loss program within 6 months
- •Noninvasive treatment for OSA within 1 month (self-report)
- •History of shift work or rotating shifts within 1 month
研究组 & 干预措施
Dronabinol
Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks.
干预措施: Dronabinol (Drug)
Placebo
Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of times subjects complete CPAP therapy
时间窗: Baseline
CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night
Apnea-hypopnea index (AHI)
时间窗: Day 15, Day 29, and Day 42
Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (\<5) to Severe (\>30).
International Physical Activity Questionnaire
时间窗: Baseline and Day 42
International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality
次要结局
- 24-hour blood pressure(Baseline and Day 42)
- Blood Pressure(Baseline, Day 22, and Day 42)
研究者
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic