Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2024-08-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This is a double-blind, randomized, placebo-controlled, single site clinical trial.

Study Groups

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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.

Group Type EXPERIMENTAL

Baseline surveys, Cognitive testing and EMAs

Intervention Type 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.

Actiwatch

Intervention Type DEVICE

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

suvorexant (or placebo)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Baseline surveys, Cognitive testing and EMAs

Intervention Type 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.

Actiwatch

Intervention Type DEVICE

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

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Actiwatch

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

Intervention Type DEVICE

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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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ecological momentary assessment actigraphy Belsomra no drug

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No