Skip to main content
OpenTrials
Completed

NCT Number: NCT05908526

Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline surveys, Cognitive testing and EMAs

Behavioral

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

Actiwatch

Device

Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.

Other names: actigraphy

suvorexant (or placebo)

Drug

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

Other

An inactive substance that looks like the drug or treatment being tested.

Other names: no drug

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.