Effect of Trazodone on Obstructive Sleep Apnea Endotypes and 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 trazodone 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 trazodone administered before sleep on OSA traits and OSA severity during sleep.
详细描述
Two overnight home 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 be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. 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 30 min before sleep
干预措施: Placebo oral tablet (Drug)
Trazodone
Trazodone capsule 30 min before sleep
干预措施: Trazodone Hydrochloride (Drug)
结局指标
主要结局
Effect of trazodone on arousal threshold (%eupnea)
时间窗: 1 night
Arousal threshold will be calculated non invasively from the home sleep test flow signal
次要结局
- Effect of trazodone on apnea hypopnea index (events/h)(1 night)
研究者
Ludovico Messineo
Assistant Professor
Brigham and Women's Hospital