The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Sleep apnea severity index
研究概览
简要总结
The investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (OSA) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype OSA.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnic ischemic stroke patients with OSA and depression.
排除标准
- •unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis.
- •overnight mean oxygen saturation (SaO2) nadir is ≤ 70% at baseline
- •take monoamine oxidase inhibitors (MAOI), any medication that may affect breathing, sleep, or muscle activity
- •any known allergy to trazodone
- •sleep disorder other than OSA (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/Cheyne-Stokes respiration).
研究组 & 干预措施
Trazodone
take trazodone 100mg hs
干预措施: Trazodone (Drug)
Placebo
take placebo pill hs
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Sleep apnea severity index
时间窗: the polysomnography study night before take drug
apnea-hypopnea index, desaturation index according to The American Academy of Sleep Medicine (AASM) scoring manual version 2.0.3: Obstructive apnea: no airflow \>= 10 s with respiratory effort (per hour of time); central apnea: no airflow without respiratory effort (per hour of time). Hypopnea: airflow decrease \>30% lasting \>= 10 s, followed by either oxygen desaturation \> 3% or EEG arousal (per hour of time). The desaturation index: number of desaturations per hour of time.
nocturnal oxygen saturation
时间窗: the polysomnography study night before take drug
mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study
次要结局
未报告次要终点
研究者
CHEN,CHUNG YAO
doctor
Chang Gung Memorial Hospital