Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 2

Conditions: Insomnia

Treatments: Device: Actiwatch; Drug: suvorexant (or placebo); Other: Placebo; Behavioral: Baseline surveys, Cognitive testing and EMAs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05908526

HP-00100622

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Baseline surveys, Cognitive testing and EMAs

Drug: suvorexant (or placebo)

Device: Actiwatch

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Baseline surveys, Cognitive testing and EMAs

Other: Placebo

Device: Actiwatch