Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908526
• Other study ID #: HP-00100622
• Status: Recruiting
• Phase: Phase 2
• Start date: October 9, 2023
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: Emerson M Wickwire, PhD
• Phone: 410-706-4771
• Email: ewickwire[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

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

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

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (4)

Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23. — View Citation

Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8. — View Citation

Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415. — View Citation

Wickwire EM, Verceles AC, Chen S, Zhao Z, Rogers VE, Wilckens KA, Buysse DJ. Smart Phone/Ecological Momentary Assessment of Sleep and Daytime Symptoms Among Older Adults With Insomnia. Am J Geriatr Psychiatry. 2023 May;31(5):372-378. doi: 10.1016/j.jagp.2023.01.020. Epub 2023 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (start of study) and end of study (before day 16).
Secondary	Change in Sleep Parameters Assessed by Sleep Diaries	Sleep continuity (total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality) measured by daily sleep diaries. This is a self-report measure in which total sleep time, sleep onset latency, and wake after sleep onset are in minutes. Sleep efficiency is a percentage. Sleep quality is a scale that ranges from 1 to 10, with higher scores indicating greater sleep quality.	Baseline (start of study) and end of study (before day 16).
Secondary	Change in Sleep Parameters Assessed by Actigraphy	Sleep parameters (total sleep time, wake after sleep onset, sleep efficiency) as measured by actigraphy. This is an objective measure where total sleep time and wake after sleep onset are in minutes, and sleep efficiency is a percentage.	Baseline (start of study) and end of study (before day 16).
Secondary	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.	Baseline (start of study) and end of study (before day 16).
Secondary	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.	Baseline (start of study) and end of study (before day 16).
Secondary	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.	Baseline (start of study) and end of study (before day 16).
Secondary	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.	Baseline (start of study) and end of study (before day 16).
Secondary	Change in Cognitive Performance Assessed by the PVT (psychomotor vigilance test)	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.	Baseline (start of study) and end of study (before day 16).
Secondary	Change in Cognitive Performance Assessed by the Stroop test	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.	Baseline (start of study) and end of study (before day 16).
Secondary	Change in Cognitive Performance Assessed by the Task-switching	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.	Baseline (start of study) and end of study (before day 16).