The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults With Insomnia: A Placebo-controlled, Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Daytime Insomnia Symptoms Scale (DISS)
研究概览
简要总结
The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.
详细描述
The study will take about six to eight weeks to complete. Participants will have a home sleep apnea test (HSAT) and complete a clinical interview. Participants will also complete a baseline assessment, which will take place over one or two days (about 3 hours total).
During the study, participants will complete research questionnaires and cognitive testing at baseline and post-baseline (after treatment). Participants will also complete brief EMA surveys (sleep diary and Daytime Insomnia Symptoms Scale) via mobile device 4 times per day for approximately 16 days; each survey will take about 2 minutes or less to complete. Participants will also wear an actigraph on the non-dominant wrist. This device looks like a wristwatch and measures ambulatory movement, a validated proxy for sleep.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind, randomized, placebo-controlled, single site clinical trial.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.
- •Insomnia Severity Index total score >
- •Insomnia symptoms must include problems with wake after sleep onset.
- •Insomnia symptom duration > 6 months.
- •Baseline self-reported total sleep time < 6.5 hours per night.
排除标准
- •High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.
- •Current diagnosis of a major untreated psychiatric disorder(s).
- •History of serious suicide attempt within past 5 years.
- •History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.
- •Heavy alcohol consumption (e.g., >5 drinks per day or > 14 drinks per week.
- •Heavy caffeine use [(>2 cups of coffee/day (equivalent).
- •Current tobacco or nicotine use.
- •History of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics.
- •CYP3A inhibitors.
- •Refusal to discontinue or intention to initiate OTC or other sleep aids during study period.
研究组 & 干预措施
Treatment
Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy.
干预措施: Baseline surveys, Cognitive testing and EMAs (Behavioral)
Treatment
Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy.
干预措施: Actiwatch (Device)
Treatment
Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy.
干预措施: suvorexant (or placebo) (Drug)
Placebo
Participants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy.
干预措施: Baseline surveys, Cognitive testing and EMAs (Behavioral)
Placebo
Participants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy.
干预措施: Actiwatch (Device)
Placebo
Participants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Daytime Insomnia Symptoms Scale (DISS)
时间窗: Baseline (start of study) and end of study (before day 16).
This measure assesses daytime symptoms and functional impairments in five domains: alert cognition, fatigue, sleepiness, negative mood, and positive mood. Participants will complete this survey four times per day on their smart phone for approximately 16 days. The possible score range is 0-100, with higher scores indicating greater levels of a given construct.
Change in Insomnia Severity as Assessed by Insomnia Severity Index
时间窗: Baseline (start of study) and end of study (before day 16).
The Insomnia Severity Index is a brief self-report instrument that measures subjective symptoms and consequences of insomnia as well as the degree of distress caused by those difficulties. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
次要结局
- Change in Sleepiness as Assessed by Epworth Sleepiness Scale(Baseline (start of study) and end of study (before day 16).)
- Change in Depression as Assessed by Patient Health Questionnaire-9(Baseline (start of study) and end of study (before day 16).)
- Change in Anxiety as Assessed by Generalized Anxiety Disorder-7(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the Stroop Test: Accuracy(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds(Baseline (start of study) and end of study (before day 16).)
- Change in Cognitive Performance Assessed by the Task-switching(Baseline (start of study) and end of study (before day 16).)
研究者
Emerson Wickwire
Professor, Psychiatry and Medicine; Section Head, Sleep Medicine
University of Maryland, Baltimore