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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline surveys, Cognitive testing and EMAs | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson M Wickwire, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18509902 | Background | 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. | |
| 17368098 | Background | 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. |
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No plan to make individual participant data (IPD) available to other researchers at this time.
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The study participants that were confirmed eligible were randomized to drug or placebo in a 1:1 ratio by the IDS pharmacy.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Older adults with insomnia. | Posted | Mean | Standard Deviation | units on a scale | Baseline (start of study) and end of study (before day 16). |
|
From enrollment until end of follow-up, up to 16 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limitations include unknown generalizability of our non-random sample of generally well-educated individuals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emerson Wickwire, PhD | University of Maryland, Baltimore | 410-706-4771 | ewickwire@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2025 | Sep 16, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Aug 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D009483 | Neuropsychological Tests |
| D000072860 | Ecological Momentary Assessment |
| D056044 | Actigraphy |
| C551624 | suvorexant |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
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This is a double-blind, randomized, placebo-controlled, single site clinical trial.
|
| Actiwatch | Device | Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion. |
|
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| 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. |
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| Placebo | Other | An inactive substance that looks like the drug or treatment being tested. |
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| 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). |
| 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). |
| Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses | 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). |
| Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time | 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). |
| Change in Cognitive Performance Assessed by the Stroop Test: Accuracy | 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). |
| Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds | 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. | Baseline (start of study) and end of study (before day 16). |
| Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds | 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. | Baseline (start of study) and end of study (before day 16). |
| 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). |
| 28427826 | Background | 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. |
| 36813640 | Background | 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. |
| 41490112 | Derived | Wickwire EM, Zhou J, Chen S, Wilckens KA, Steenbergh TA, Buysse DJ, Verceles AC. Smartphone-Based Real-Time Assessment of Daytime Insomnia Symptoms With Suvorexant: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550186. doi: 10.1001/jamanetworkopen.2025.50186. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants randomized to placebo (PBO)
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| Primary | 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. | Older adults with insomnia. | Posted | Mean | Standard Deviation | units on a scale | Baseline (start of study) and end of study (before day 16). |
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|
| 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. | Older adults with insomnia | Posted | Mean | Standard Deviation | units on a scale | 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. | Older adults with insomnia. | Posted | Mean | Standard Deviation | units on a scale | 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. | Older adults with insomnia. | Posted | Mean | Standard Deviation | units on a scale | Baseline (start of study) and end of study (before day 16). |
|
|
|
| Secondary | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses | 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. | Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group). | Posted | Mean | Standard Deviation | Lapses (reaction time >500 milliseconds) | Baseline (start of study) and end of study (before day 16). |
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| Secondary | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time | 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. | Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group). | Posted | Median | Standard Deviation | Reaction Time (milliseconds) | Baseline (start of study) and end of study (before day 16). |
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| Secondary | Change in Cognitive Performance Assessed by the Stroop Test: Accuracy | 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. | Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group). | Posted | Mean | Standard Deviation | Number of Errors | Baseline (start of study) and end of study (before day 16). |
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| Secondary | Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds | 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. | Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group). | Posted | Mean | Standard Deviation | Response time in milliseconds | Baseline (start of study) and end of study (before day 16). |
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| Secondary | Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds | 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. | Older adults with insomnia. Usable data was not available for six participants (three in each treatment group). | Posted | Mean | Standard Deviation | Response Time (milliseconds) | Baseline (start of study) and end of study (before day 16). |
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| 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. | Older adults with insomnia. Usable data was not available for six participants (three in each treatment group). | Posted | Mean | Standard Deviation | Number of Errors | Baseline (start of study) and end of study (before day 16). |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001523 |
| Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |