The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Sleep Continuity
研究概览
简要总结
Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.
详细描述
The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism [wake extension]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding only applies to the medication arm. The randomization schedule was developed by our statistician and sent directly to research pharmacy for implementation.
The four arms are as follows:
- Solriamfetol + CBT-I
- Placebo + CBT-I
- Solriamfetol Only
- Placebo Only
All conditions engage in monitoring and assessment.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- •In addition, the complaint of disturbed sleep will meet the following criteria:
- •≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency [SE] is ≤ 80%).
- •The problem is present for > 3 nights per week.
- •The problem duration exceeds ≥ 6 months.
- •The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
- •Preferred regular sleep phase between 10:00 PM and 8:00 AM
- •Must garner physician's assent from their primary care clinician
排除标准
- •Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
- •Night shift work
- •Compromised renal function
- •Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
- •Planning to become pregnant, pregnant, and/or breastfeeding
- •Unstable medical or psychiatric illness
- •Symptoms suggestive of sleep disorders other than insomnia
- •Polysomnographic data indicating sleep disorders other than insomnia
- •Evidence of active illicit substance use, abuse, or dependence
- •Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
- •Inadequate language comprehension
- •Current or past experience with CBT-I
- •No access to the computers, I-Pads, or the internet
研究组 & 干预措施
Solriamfetol Only
干预措施: Monitoring (Other)
Solriamfetol+ CBT-I
干预措施: Solriamfetol 75 MG (Drug)
Solriamfetol Only
干预措施: Solriamfetol 75 MG (Drug)
Solriamfetol+ CBT-I
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Placebo + CBT-I
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Placebo + CBT-I
干预措施: Placebo (Other)
Placebo Only
干预措施: Monitoring (Other)
Placebo Only
干预措施: Placebo (Other)
结局指标
主要结局
Sleep Continuity
时间窗: End of Treatment (12 Weeks)
Reflected by total wake time \[time spent awake in bed\] as measured via a web based self-report Sleep Diary. This variable is calculated by summing the estimates for sleep latency (SL), sleep after wake onset (WASO), and early morning awakening (EMA).
次要结局
- Insomnia Severity(End of Treatment (12 Weeks))
- Daytime Sleepiness(End of Treatment (12 Weeks))
- Fatigue(End of Treatment (12 Weeks))
- Adherence to "sleep rescheduling"(Throughout treatment (over 8 weeks))
- Daytime Function(End of Treatment (12 Weeks))
- Mood Disturbance(End of Treatment (12 Weeks))
- Alertness(Throughout treatment (over 8 weeks))