Effect of Atomoxetine and DAW2022 on OSA Severity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Effect of atomoxetine and DAW2020 on OSA severity
研究概览
简要总结
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.
详细描述
Two overnight sleep studies will be performed: a drug night and a placebo night, with a month of washout between treatments. 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 polysomnography 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. The drugs will be administered as follows. There will be a 3-day run in of atomoxetine 40 mg followed by atomoxetine 80 mg starting on the fourth night until the night of the study. DAW2020 34 mg will be administered for 1-week to allow adequate plasma concentrations to be reached. For the sleep study, at least four hours of sleep (50% in the supine position) will be monitored to assess sleep and respiratory variables.
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 oral capsules
Placebo (2 pills) before sleep for a week
干预措施: Placebo oral capsule (Drug)
Atomoxetine and DAW2020 oral capsules
DAW2020 34 mg 4 h before sleep, single night administration for a week. Simultaneous administration of atomoxetine 40 mg for 3 days 30 min before sleep, 80 mg for the following 4 days, 30 min before sleep
干预措施: Atomoxetine Oral Capsule [Strattera] (Drug)
结局指标
主要结局
Effect of atomoxetine and DAW2020 on OSA severity
时间窗: 1 week
OSA severity will be quantified by the number of respiratory events/h (AHI)
次要结局
- Effect of atomoxetine and DAW2020 on arousal index(1 week)
- Effect of atomoxetine and DAW2020 on nadir oxygen desaturation(1 week)
研究者
David Andrew Wellman
Associate Professor of Medicine
Brigham and Women's Hospital