Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

NCT05908526 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: HP-00100622
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

Secondary Outcomes (9)

• 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).

Study Arms (2)

Treatment

EXPERIMENTAL

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; Device: Actiwatch; Drug: suvorexant (or placebo)

Placebo

PLACEBO COMPARATOR

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; Device: Actiwatch; Other: Placebo

Interventions

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.

Also known as: ecological momentary assessment

Placebo; Treatment

Actiwatch DEVICE

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

Also known as: actigraphy

Placebo; Treatment

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.

Also known as: Belsomra

Treatment

Placebo OTHER

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

Also known as: no drug

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (5)

• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

  PMID: 18509902 BACKGROUND

• Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23.

  PMID: 17368098 BACKGROUND

• Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.

  PMID: 28427826 BACKGROUND

• Wickwire EM, Verceles AC, Chen S, Zhao Z, Rogers VE, Wilckens KA, Buysse DJ. Smart Phone/Ecological Momentary Assessment of Sleep and Daytime Symptoms Among Older Adults With Insomnia. Am J Geriatr Psychiatry. 2023 May;31(5):372-378. doi: 10.1016/j.jagp.2023.01.020. Epub 2023 Feb 1.

  PMID: 36813640 BACKGROUND

• Wickwire EM, Zhou J, Chen S, Wilckens KA, Steenbergh TA, Buysse DJ, Verceles AC. Smartphone-Based Real-Time Assessment of Daytime Insomnia Symptoms With Suvorexant: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550186. doi: 10.1001/jamanetworkopen.2025.50186.

  PMID: 41490112 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Surveys and Questionnaires; Neuropsychological Tests; Ecological Momentary Assessment; Actigraphy; suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Psychological Tests; Behavioral Disciplines and Activities; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry

Limitations and Caveats

Limitations include unknown generalizability of our non-random sample of generally well-educated individuals.

Results Point of Contact

• Title: Emerson Wickwire, PhD
• Organization: University of Maryland, Baltimore

ewickwire@som.umaryland.edu

410-706-4771

Study Officials

• Emerson M Wickwire, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, randomized, placebo-controlled, single site clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Medicine; Section Head, Sleep Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 18, 2023
• Study Start: October 9, 2023
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)