Clinical trial NCT05908526: Insomnia Treatment and EMA (ecological Momentary Assessment) Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Daytime Insomnia Symptoms Scale (DISS)
timeFrame: Baseline (start of study) and end of study (before day 16).
Secondary outcomes:
measure: Change in Sleep Parameters Assessed by Sleep Diaries
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in Sleep Parameters Assessed by Actigraphy
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in insomnia severity as assessed by Insomnia Severity Index
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in sleepiness as assessed by Epworth Sleepiness Scale
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in depression as assessed by Patient Health Questionnaire-9
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in anxiety as assessed by Generalized Anxiety Disorder-7
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in Cognitive Performance Assessed by the PVT (psychomotor vigilance test)
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in Cognitive Performance Assessed by the Stroop test
timeFrame: Baseline (start of study) and end of study (before day 16).
measure: Change in Cognitive Performance Assessed by the Task-switching
timeFrame: Baseline (start of study) and end of study (before day 16).
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Emerson M Wickwire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.