University of Maryland, Baltimore

Insomnia Treatment and EMA (ecological Momentary Assessment) Outcomes

Purpose

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.

Condition

Insomnia

Eligibility

Eligible Ages: Between 60 Years and 85 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a double-blind, randomized, placebo-controlled, single site clinical trial.

Arm Groups

Arm	Description	Assigned Intervention
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

More Details

Status: Completed
Sponsor: University of Maryland, Baltimore

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.