Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
研究概览
简要总结
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both prescribing physicians and participants will be blind to phenotype and treatment groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- •Meets criteria for chronic insomnia
- •Body Mass Index (BMI) 18.5 kg/m2 and higher
排除标准
- •Age < 18
- •Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- •Unwilling to share email address/cell phone number to accept survey links.
- •Life time diagnosis of psychotic or bipolar disorder
- •History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
- •Started new or changed treatment for sleep apnea in the past three months
- •Does not meet criteria for chronic insomnia
- •Meets criteria for narcolepsy or hypersomnia disorder
- •Meets criteria for circadian rhythm disorder (including night shift work)
- •Unstable medical conditions that would make participation unsafe or unfeasible
- •Falls resulting in hospitalization, significant injury or fracture within past 12 months
- •2 hospitalizations or emergency room visits within past 12 months for chronic conditions
- •Active chemotherapy or radiation therapy for cancer
- •Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
- •Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
- •BMI less than 18.5
- •Substance abuse or dependence in the past 12 months
- •Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
- •Current use of systemic corticosteroids or opiate medications
- •Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
- •Current use of medications contraindicated with trazodone
- •Sleep apnea or periodic leg movement disorder as determined by sleep study
- •Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
- •EKG corrected QT interval greater than or equal to 500 ms
研究组 & 干预措施
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
干预措施: Cognitive Behavioral Treatment for Insomnia (CBT-I) (Behavioral)
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
干预措施: Placebo (Other)
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
干预措施: Cognitive Behavioral Treatment for Insomnia (CBT-I) (Behavioral)
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
干预措施: Trazodone (Drug)
结局指标
主要结局
Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
时间窗: 9 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
时间窗: 35 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
时间窗: 9 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
次要结局
- Evening Cortisol levels following CBT-I(9 weeks)
- Evening Cortisol levels following RCT(9 weeks)
- Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)(9 weeks)
- Insomnia Severity Index (ISI) Score following CBT-I(9 weeks)
- Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)(9 weeks)
- Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)(9 weeks)
- PSG Total Sleep Time (TST) following RCT(9 weeks)
- Actigraphy Total Sleep Time (TST) following RCT(9 weeks)
- Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)(9 weeks)
- Insomnia Severity Index (ISI) Score following RCT(9 weeks)
- Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment(35 weeks)
研究者
Alexandros Vgontzas
Professor, Department of Psychiatry
Milton S. Hershey Medical Center