Back to resultsInsomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
Primary Purpose
Insomnia
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baseline surveys, Cognitive testing and EMAs
Actiwatch
suvorexant (or placebo)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
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.
Sites / Locations
- University of Maryland, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05908526
First Posted
May 11, 2023
Last Updated
June 9, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05908526
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
This is a double-blind, randomized, placebo-controlled, single site clinical trial.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baseline surveys, Cognitive testing and EMAs
Other Intervention Name(s)
ecological momentary assessment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Actiwatch
Other Intervention Name(s)
actigraphy
Intervention Description
Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.
Intervention Type
Drug
Intervention Name(s)
suvorexant (or placebo)
Other Intervention Name(s)
Belsomra
Intervention Description
FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
no drug
Intervention Description
An inactive substance that looks like the drug or treatment being tested.
Primary Outcome Measure Information:
Title
Change in Daytime Insomnia Symptoms Scale (DISS)
Description
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).
Secondary Outcome Measure Information:
Title
Change in Sleep Parameters Assessed by Sleep Diaries
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
Title
Change in Sleep Parameters Assessed by Actigraphy
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
Title
Change in insomnia severity as assessed by Insomnia Severity Index
Description
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).
Title
Change in sleepiness as assessed by Epworth Sleepiness Scale
Description
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).
Title
Change in depression as assessed by Patient Health Questionnaire-9
Description
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).
Title
Change in anxiety as assessed by Generalized Anxiety Disorder-7
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
Title
Change in Cognitive Performance Assessed by the PVT (psychomotor vigilance test)
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
Title
Change in Cognitive Performance Assessed by the Stroop test
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
Title
Change in Cognitive Performance Assessed by the Task-switching
Description
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.
Time Frame
Baseline (start of study) and end of study (before day 16).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emerson M Wickwire, PhD
Phone
410-706-4771
Email
ewickwire@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine E Wade Johnston
Phone
410-706-1486
Email
christine.johnston@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emerson M Wickwire, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Johnston
First Name & Middle Initial & Last Name & Degree
Avelino Verceles, MD
First Name & Middle Initial & Last Name & Degree
Shuo Chen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data (IPD) available to other researchers at this time.
Citations:
PubMed Identifier
18509902
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.
Results Reference
background
PubMed Identifier
17368098
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.
Results Reference
background
PubMed Identifier
28427826
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.
Results Reference
background
PubMed Identifier
36813640
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.
Results Reference
background
Learn more about this trial
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
We'll reach out to this number within 24 hrs