Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
研究概览
简要总结
The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.
详细描述
Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT, with a 6 month follow up. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic insomnia with duration of more than 1 year
- •Objective short sleep duration (< 6 hours)
- •BMI < 39
- •Ages 30-60
- •Men & Women
排除标准
- •Major Mental Illness
- •Substance Abuse/Dependence
- •Sleep Apnea
- •Periodic Limb Movement Disorder
- •Shift Work or circadian disorders
- •Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
- •Current Use of hypnotics or sleep inducing sedative antidepressants
研究组 & 干预措施
Trazodone
干预措施: Trazodone (Drug)
Cognitive Behavioral Therapy
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
时间窗: Baseline to Post Treatment (3 months)
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)
时间窗: Baseline to follow up (9 months)
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)
时间窗: Baseline to Post Treatment (3 months)
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)
时间窗: Baseline to follow up (9 months)
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
次要结局
- Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months(Baseline to Post Treatment (3 months))
- Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months(Baseline to follow up (9 months))
研究者
Alexandros Vgontzas
Principal Investigator
Milton S. Hershey Medical Center