Cannabimimetic Treatment of Obstructive Sleep Apnea: A Proof of Concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Apnea/Hypopnea Index (AHI)
研究概览
简要总结
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 21 to 64 years of age;
- •15≤AHI ≤ 50 on screening polysomnogram (PSG)
- •ESS score ≥ 7
- •Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format;
- •Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
排除标准
- •Arterial oxygen saturation < 75% for > 5% of sleep period time on screening PSG;
- •Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
- •Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
- •Body mass index > 45 kg/m2
- •Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
- •History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8);
- •Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age);
- •Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8);
- •Major surgery within 6 months prior to the first dose of study drug (Day 8);
- •Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8).
- •Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8);
- •Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis;
- •Any clinically significant unstable or progressive medical condition;
- •Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period);
- •Clinically significant or uncontrolled: chronic obstructive pulmonary disease (COPD), cardiovascular disease, gastrointestinal, respiratory, pancreatic, hepatic, renal, hematologic, endocrine [including insulin-dependent diabetes mellitus (IDDM)], neurological, urogenital, connective tissue, dermatological, thyroid, or other medical disorder;
- •Any clinically significant psychiatric disorder;
- •History of seizure disorder;
- •Treatment with any prescription antidepressant medication within 1 month prior to the first dose of study drug (Day 8);
- •Treatment with sedatives, hypnotics or other psychoactive drugs within 30 days prior to the first dose of study drug (Day 8);
- •Any complete blood count (CBC) or liver function test (LFT) laboratory value outside the normal range which, in the clinical judgment of the Investigator renders a subject inappropriate for randomization to treatment;
- •Pregnancy [as demonstrated by positive urine human chorionic gonadotropin (hCG) test] or lactation;
- •Allergic to cannabinoids or sesame oil;
- •History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel;
- •Use of dietary supplements which in the judgment of the Investigator may impact sleep or breathing behaviors;
- •Average daily caffeine consumption > 500 mg/day (~5 cups of coffee);
- •Average weekly alcohol consumption > 10 units;
- •Unwillingness to abstain from caffeine and alcohol on all days when overnight or daytime testing will be performed;
- •Participation in any other investigational protocol within the 30 days prior to the first dose of study drug (Day 8);
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.
研究组 & 干预措施
2.5 mg/day
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
干预措施: Dronabinol (Drug)
Sugar Pill
Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in
干预措施: Placebo (for Dronabinol) (Drug)
10 mg/day
Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation
干预措施: Dronabinol (Drug)
结局指标
主要结局
Change in Apnea/Hypopnea Index (AHI)
时间窗: Baseline and Week 6
Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)
时间窗: Baseline and Week 6
Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.
Change in Epworth Sleepiness Scale (ESS)
时间窗: Baseline and Week 6
Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.
次要结局
- Adverse Events (AEs)(Up to 8 weeks)
- Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.(Week 6)
- Change in Desaturation Time (DT)(6 weeks)
研究者
David W. Carley
Professor
University of Illinois at Chicago