Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Baseline surveys, Cognitive testing and EMAs
* Device: Actiwatch
* Drug: suvorexant (or placebo)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder. Insomnia Severity Index total score >10. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study employs a two-group (suvorexant, 20mg, qhs, versus placebo) parallel design and involves a baseline assessment, 2-day low-dose run-in, and approximately 14-day active treatment phase with intensive ambulatory monitoring via wrist actigraphy and ecological momentary assessment (EMA). Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and objective cognitive testing administered by computer.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Behavioral: Baseline surveys, Cognitive testing and EMAs<br>* Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and cognitive testing administered by computer.<br>* Other names: ecological momentary assessment;Device: Actiwatch<br>* Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.<br>* Other names: actigraphy;Drug: suvorexant (or placebo)<br>* FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.<br>* Other names: Belsomra;|
| Placebo Comparator: Placebo<br>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. | Behavioral: Baseline surveys, Cognitive testing and EMAs<br>* Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and cognitive testing administered by computer.<br>* Other names: ecological momentary assessment;Device: Actiwatch<br>* Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.<br>* Other names: actigraphy;Other: Placebo<br>* An inactive substance that looks like the drug or treatment being tested.<br>* Other names: no drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daytime Insomnia Symptoms Scale (DISS) | 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. | Baseline (start of study) and end of study (before day 16). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Parameters Assessed by Sleep Diaries | Sleep continuity (total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality) measured by daily sleep diaries. This is a self-report measure in which total sleep time, sleep onset latency, and wake after sleep onset are in minutes. Sleep efficiency is a percentage. Sleep quality is a scale that ranges from 1 to 10, with higher scores indicating greater sleep quality. | Baseline (start of study) and end of study (before day 16). | 
| Change in Sleep Parameters Assessed by Actigraphy | Sleep parameters (total sleep time, wake after sleep onset, sleep efficiency) as measured by actigraphy. This is an objective measure where total sleep time and wake after sleep onset are in minutes, and sleep efficiency is a percentage. | Baseline (start of study) and end of study (before day 16). | 
| Change in insomnia severity as assessed by Insomnia Severity Index | 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. | Baseline (start of study) and end of study (before day 16). | 
| Change in sleepiness as assessed by Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a brief self-report instrument that measures daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater severity of sleepiness. | Baseline (start of study) and end of study (before day 16). | 
| Change in depression as assessed by Patient Health Questionnaire-9 | The Patient Health Questionnaire-9 is a brief self-report instrument that measures depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. | Baseline (start of study) and end of study (before day 16). | 
| Change in anxiety as assessed by Generalized Anxiety Disorder-7 | The Generalized Anxiety Disorder-7 is a brief self-report instrument that measures anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater levels of depressive symptoms. | Baseline (start of study) and end of study (before day 16). | 
| Change in Cognitive Performance Assessed by the PVT (psychomotor vigilance test) | PVT is a computer-based, chronometric test to measure reactions to specified small changes in a changing environment. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy. | Baseline (start of study) and end of study (before day 16). | 
| Change in Cognitive Performance Assessed by the Stroop test | Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy. | Baseline (start of study) and end of study (before day 16). | 
| Change in Cognitive Performance Assessed by the Task-switching | Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy. | Baseline (start of study) and end of study (before day 16). |