Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Last updated: October 2, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Completed

Phase

2

Condition

Insomnia

Treatment

Placebo

Baseline surveys, Cognitive testing and EMAs

suvorexant (or placebo)

Clinical Study ID

NCT05908526
HP-00100622
  • Ages 60-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteriafor 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

Exclusion Criteria:

  • High risk for untreated organic sleep disorders other than insomnia (narcolepsy,periodic limb movement disorder, etc) as determined by structured clinical interviewand 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 tosedative hypnotics.

  • CYP3A inhibitors.

  • Refusal to discontinue or intention to initiate OTC or other sleep aids during studyperiod.

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 09, 2023
Estimated Completion Date:
August 08, 2024

Study 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.

Connect with a study center

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland, Baltimore

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

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