Effect of DAW2020 on Endotypic Traits in OSA
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effects of DAW2020 on arousal threshold (%eupnea)
研究概览
简要总结
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of DAW2020 administered before sleep on OSA phenotype traits and OSA severity during sleep.
详细描述
Two overnight sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. DAW2020 34 mg will be given 4 hours before lights out. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-severe OSA (AHI ≥ 15 events/hr)
排除标准
- •All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
- •Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- •Use of SNRIs/SSRIs.
- •Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
- •Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
- •Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
- •Hypersensitivity to the study drug (angioedema or urticaria)
- •Contraindications to DAW2020
- •Use of medications that lengthen QTc interval
- •Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
- •Severe claustrophobia.
研究组 & 干预措施
Placebo
Placebo capsule 4 hours before sleep
干预措施: Placebo oral capsule (Drug)
DAW2020
DAW2020 capsule 4 hours before sleep
干预措施: DAW2020 oral capsule (Drug)
结局指标
主要结局
Effects of DAW2020 on arousal threshold (%eupnea)
时间窗: 1 night
Arousal threshold will be calculated using diaphragm EMG
次要结局
未报告次要终点
研究者
David Andrew Wellman
Associate professor of Medicine
Brigham and Women's Hospital