Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults With Insomnia: A Placebo-controlled, Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05908526

Enrollment

Registered

2023-06-18

Start date

2023-10-09

Completion date

2024-08-08

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

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.

Interventions

BEHAVIORALBaseline 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.

DEVICEActiwatch

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

DRUGsuvorexant (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.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

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

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.

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Daytime Insomnia Symptoms Scale (DISS)	Baseline (start of study) and end of study (before day 16).	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.
Change in Insomnia Severity as Assessed by Insomnia Severity Index	Baseline (start of study) and end of study (before day 16).	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.

Secondary

Measure	Time frame	Description
Change in Anxiety as Assessed by Generalized Anxiety Disorder-7	Baseline (start of study) and end of study (before day 16).	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.
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses	Baseline (start of study) and end of study (before day 16).	PVT is a computer-based, chronometric test to measure reactions to specified small changes in a changing environment. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
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).	PVT is a computer-based, chronometric test to measure reactions to specified small changes in a changing environment. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Change in Sleepiness as Assessed by Epworth Sleepiness Scale	Baseline (start of study) and end of study (before day 16).	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.
Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds	Baseline (start of study) and end of study (before day 16).	Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in milliseconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds	Baseline (start of study) and end of study (before day 16).	Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in milliseconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Change in Cognitive Performance Assessed by the Task-switching	Baseline (start of study) and end of study (before day 16).	Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Change in Cognitive Performance Assessed by the Stroop Test: Accuracy	Baseline (start of study) and end of study (before day 16).	Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Change in Depression as Assessed by Patient Health Questionnaire-9	Baseline (start of study) and end of study (before day 16).	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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited to the study in several ways (i.e., volunteer lists, mailings based on EPIC searches, newspaper advertisements, online and social media advertisements, public presentations, and word of mouth and study fliers). The participants were provided with study staff contact information, and the participant called. For online and social media, advertisements, and recruitment pathways, if interested the participant would complete online preliminary screening questionnaire.

Pre-assignment details

The study participants that were confirmed eligible were randomized to drug or placebo in a 1:1 ratio by the IDS pharmacy.

Participants by arm

Arm	Count
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.	20
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.	20
Total	40

Baseline characteristics

Characteristic	Treatment	Placebo	Total
Age, Customized 60 to 69 years old	12 Participants	12 Participants	24 Participants
Age, Customized 70 to 79 years old	8 Participants	8 Participants	16 Participants
Age, Customized 80-85 years old	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	7 Participants	5 Participants	12 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	12 Participants	13 Participants	25 Participants
Sex: Female, Male Female	18 Participants	18 Participants	36 Participants
Sex: Female, Male Male	2 Participants	2 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary

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.