Trial · NCT05908526
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
NCT05908526, Phase 2, Completed, University of Maryland, Baltimore; results first posted 2025-10-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes. Trials, record NCT05908526. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05908526
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
- NCT number
- NCT05908526
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Insomnia
- Interventions
- Baseline surveys, Cognitive testing and EMAs, Actiwatch, suvorexant (or placebo), Placebo
- First posted
- 2023-06-18
- Last updated
- 2025-10-30
- Results first posted
- 2025-10-30
- Limitations and caveats
- Limitations include unknown generalizability of our non-random sample of generally well-educated individuals.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Daytime Insomnia Symptoms Scale (DISS) | Baseline (start of study) and end of study (before day 16). | 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. |
| Primary | Change in Insomnia Severity as Assessed by Insomnia Severity Index | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Sleepiness as Assessed by Epworth Sleepiness Scale | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Depression as Assessed by Patient Health Questionnaire-9 | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Cognitive Performance Assessed by the Stroop Test: Accuracy | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds | Baseline (start of study) and end of study (before day 16). | 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. |
| Secondary | Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds | Baseline (start of study) and end of study (before day 16). | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Daytime Insomnia Symptoms Scale (DISS) | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. | units on a scale | MEAN |
| PRIMARY | Change in Insomnia Severity as Assessed by Insomnia Severity Index | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. | units on a scale | MEAN |
| SECONDARY | Change in Sleepiness as Assessed by Epworth Sleepiness Scale | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia | units on a scale | MEAN |
| SECONDARY | Change in Depression as Assessed by Patient Health Questionnaire-9 | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. | units on a scale | MEAN |
| SECONDARY | Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. | units on a scale | MEAN |
| SECONDARY | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group). | Lapses (reaction time >500 milliseconds) | MEAN |
| SECONDARY | Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. Usable data was not available for ten participants (five in each treatment group). | Reaction Time (milliseconds) | MEDIAN |
| SECONDARY | Change in Cognitive Performance Assessed by the Stroop Test: Accuracy | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group). | Number of Errors | MEAN |
| SECONDARY | Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. Usable data was not available for ten participants (six in the treatment group and four in the placebo group). | Response time in milliseconds | MEAN |
| SECONDARY | Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds | Baseline (start of study) and end of study (before day 16). | Older adults with insomnia. Usable data was not available for six participants (three in each treatment group). | Response Time (milliseconds) | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Daytime Insomnia Symptoms Scale (DISS) | Treatment | Alert Cognition morning | 65.96 | Standard Deviation 21.66 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Placebo | Alert Cognition morning | 70.34 | Standard Deviation 19.63 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Treatment | Alert Cognition midday | 69.22 | Standard Deviation 20.30 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Placebo | Alert Cognition midday | 72.32 | Standard Deviation 18.45 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Treatment | Alert Cognition afternoon | 69.72 | Standard Deviation 20.35 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Placebo | Alert Cognition afternoon | 71.08 | Standard Deviation 17.89 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Treatment | Alert Cognition evening | 67.54 | Standard Deviation 19.28 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Placebo | Alert Cognition evening | 69.05 | Standard Deviation 17.09 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Treatment | Fatigue/sleepiness morning | 36.80 | Standard Deviation 25.74 | units on a scale |
| Change in Daytime Insomnia Symptoms Scale (DISS) | Placebo | Fatigue/sleepiness morning | 35.83 | Standard Deviation 28.80 | units on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 20 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Treatment | 20 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Treatment | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Treatment | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Treatment | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Placebo: deaths from any cause | Trial comparisons |
| Treatment vs Placebo: serious adverse events | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05908526
GET https://conductscience.org/api/trials/v1/NCT05908526/results?page=2