Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

October 2, 2025 updated by: Emerson Wickwire, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Baseline surveys, Cognitive testing and EMAs
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.
Other Names:
  • ecological momentary assessment
Device: Actiwatch
Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.
Other Names:
  • actigraphy
Drug: suvorexant (or placebo)
FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Other Names:
  • Belsomra
Placebo Comparator: 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.
Behavioral: Baseline surveys, Cognitive testing and EMAs
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.
Other Names:
  • ecological momentary assessment
Device: Actiwatch
Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.
Other Names:
  • actigraphy
Other: Placebo
An inactive substance that looks like the drug or treatment being tested.
Other Names:
  • no drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daytime Insomnia Symptoms Scale (DISS)
Time Frame: 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.
Baseline (start of study) and end of study (before day 16).
Change in Insomnia Severity as Assessed by Insomnia Severity Index
Time Frame: 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.
Baseline (start of study) and end of study (before day 16).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Performance Assessed by the Task-switching
Time Frame: Baseline (start of study) and end of study (before day 16).
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).
Change in Sleepiness as Assessed by Epworth Sleepiness Scale
Time Frame: Baseline (start of study) and end of study (before day 16).
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
Time Frame: Baseline (start of study) and end of study (before day 16).
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
Time Frame: Baseline (start of study) and end of study (before day 16).
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): Lapses
Time Frame: Baseline (start of study) and end of study (before day 16).
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 PVT (Psychomotor Vigilance Test): Median Reaction Time
Time Frame: Baseline (start of study) and end of study (before day 16).
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: Accuracy
Time Frame: Baseline (start of study) and end of study (before day 16).
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 Stroop Test: Response Time in Milliseconds
Time Frame: Baseline (start of study) and end of study (before day 16).
Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in milliseconds. 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: Response Time in Milliseconds
Time Frame: Baseline (start of study) and end of study (before day 16).
Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in milliseconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Baseline (start of study) and end of study (before day 16).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Emerson M Wickwire, PhD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00100622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available to other researchers at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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