Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

University of Maryland, Baltimore40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Insomnia

Interventions

Baseline surveys, Cognitive testing and EMAsBEHAVIORAL

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.

ActiwatchDEVICE

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

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline (start of study) and end of study (before day 16).

Secondary Outcomes

Change in Sleepiness as Assessed by Epworth Sleepiness Scale

The Epworth Sleepiness Scale is a brief self-report instrument that measures daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater severity of sleepiness.

Time frame: Baseline (start of study) and end of study (before day 16).

Change in Depression as Assessed by Patient Health Questionnaire-9

The Patient Health Questionnaire-9 is a brief self-report instrument that measures depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.

Time frame: Baseline (start of study) and end of study (before day 16).

Change in Anxiety as Assessed by Generalized Anxiety Disorder-7

The Generalized Anxiety Disorder-7 is a brief self-report instrument that measures anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater levels of depressive symptoms.

Data from ClinicalTrials.gov

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