Trial Outcomes & Findings for Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes (NCT NCT05908526)
NCT ID: NCT05908526
Last Updated: 2025-10-30
Results Overview
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.
COMPLETED
PHASE2
40 participants
Baseline (start of study) and end of study (before day 16).
2025-10-30
Participant Flow
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.
The study participants that were confirmed eligible were randomized to drug or placebo in a 1:1 ratio by the IDS pharmacy.
Participant milestones
| Measure |
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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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.
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|---|---|---|
|
Overall Study
STARTED
|
20
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20
|
|
Overall Study
COMPLETED
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20
|
20
|
|
Overall Study
NOT COMPLETED
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0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
Baseline characteristics by cohort
| Measure |
Treatment
n=20 Participants
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
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
60 to 69 years old
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
70 to 79 years old
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
80-85 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia.
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.
Outcome measures
| Measure |
Treatment
n=20 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=20 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Alert Cognition morning
|
65.96 units on a scale
Standard Deviation 21.66
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70.34 units on a scale
Standard Deviation 19.63
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Alert Cognition midday
|
69.22 units on a scale
Standard Deviation 20.30
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72.32 units on a scale
Standard Deviation 18.45
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Alert Cognition afternoon
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69.72 units on a scale
Standard Deviation 20.35
|
71.08 units on a scale
Standard Deviation 17.89
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Alert Cognition evening
|
67.54 units on a scale
Standard Deviation 19.28
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69.05 units on a scale
Standard Deviation 17.09
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Fatigue/sleepiness morning
|
36.80 units on a scale
Standard Deviation 25.74
|
35.83 units on a scale
Standard Deviation 28.80
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Fatigue/sleepiness midday
|
35.52 units on a scale
Standard Deviation 23.94
|
34.03 units on a scale
Standard Deviation 27.18
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Fatigue/sleepiness afternoon
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33.01 units on a scale
Standard Deviation 24.18
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38.72 units on a scale
Standard Deviation 25.56
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Fatigue/sleepiness evening
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38.17 units on a scale
Standard Deviation 23.09
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43.58 units on a scale
Standard Deviation 26.45
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Negative Mood morning
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27.24 units on a scale
Standard Deviation 23.76
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21.71 units on a scale
Standard Deviation 22.17
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Negative Mood midday
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26.40 units on a scale
Standard Deviation 23.27
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21.60 units on a scale
Standard Deviation 21.66
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Negative Mood afternoon
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25.35 units on a scale
Standard Deviation 22.33
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21.79 units on a scale
Standard Deviation 21.66
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Negative Mood evening
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26.09 units on a scale
Standard Deviation 22.01
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21.02 units on a scale
Standard Deviation 21.74
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Positive Mood morning
|
64.42 units on a scale
Standard Deviation 21.89
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69.09 units on a scale
Standard Deviation 19.34
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Positive Mood midday
|
67.23 units on a scale
Standard Deviation 20.74
|
70.90 units on a scale
Standard Deviation 18.04
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Positive Mood afternoon
|
67.95 units on a scale
Standard Deviation 20.29
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69.98 units on a scale
Standard Deviation 18.45
|
|
Change in Daytime Insomnia Symptoms Scale (DISS)
Positive Mood evening
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66.33 units on a scale
Standard Deviation 18.99
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69.00 units on a scale
Standard Deviation 16.52
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PRIMARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia.
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.
Outcome measures
| Measure |
Treatment
n=20 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=20 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Insomnia Severity as Assessed by Insomnia Severity Index
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-9.6 units on a scale
Standard Deviation 5.4
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-5.5 units on a scale
Standard Deviation 6.8
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SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia
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.
Outcome measures
| Measure |
Treatment
n=20 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=20 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Sleepiness as Assessed by Epworth Sleepiness Scale
|
-4.2 units on a scale
Standard Deviation 3.7
|
-2.3 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia.
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.
Outcome measures
| Measure |
Treatment
n=20 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=20 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Depression as Assessed by Patient Health Questionnaire-9
|
-2.3 units on a scale
Standard Deviation 3.2
|
-2.2 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia.
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.
Outcome measures
| Measure |
Treatment
n=20 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=20 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Anxiety as Assessed by Generalized Anxiety Disorder-7
|
-3.2 units on a scale
Standard Deviation 4.1
|
-1.6 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group).
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.
Outcome measures
| Measure |
Treatment
n=15 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=15 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses
|
3.33 Lapses (reaction time >500 milliseconds)
Standard Deviation 6.08
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-1.13 Lapses (reaction time >500 milliseconds)
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group).
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.
Outcome measures
| Measure |
Treatment
n=15 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=15 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time
|
17.97 Reaction Time (milliseconds)
Standard Deviation 39.9
|
-10.23 Reaction Time (milliseconds)
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group).
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.
Outcome measures
| Measure |
Treatment
n=14 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=16 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the Stroop Test: Accuracy
|
-0.02 Number of Errors
Standard Deviation 0.19
|
0.02 Number of Errors
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group).
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.
Outcome measures
| Measure |
Treatment
n=14 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=16 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds
|
-131.3 Response time in milliseconds
Standard Deviation 626.7
|
-403.6 Response time in milliseconds
Standard Deviation 919.5
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for six participants (three in each treatment group).
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.
Outcome measures
| Measure |
Treatment
n=17 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=17 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds
|
-158.01 Response Time (milliseconds)
Standard Deviation 535.48
|
-278.42 Response Time (milliseconds)
Standard Deviation 630.74
|
SECONDARY outcome
Timeframe: Baseline (start of study) and end of study (before day 16).Population: Older adults with insomnia. Usable data was not available for six participants (three in each treatment group).
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.
Outcome measures
| Measure |
Treatment
n=17 Participants
Participants randomized to suvorexant (SUV)
|
Placebo
n=17 Participants
Participants randomized to placebo (PBO)
|
|---|---|---|
|
Change in Cognitive Performance Assessed by the Task-switching
|
0.01 Number of Errors
Standard Deviation 0.14
|
0.02 Number of Errors
Standard Deviation 0.09
|
Adverse Events
Treatment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emerson Wickwire, PhD
University of Maryland, Baltimore
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place