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NCT07397182 · ClinicalTrials.gov registry record · NA
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
A NA study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT07397182: Clinical Trial NA study, sponsored by VA Office of Research and Development.
NCT07397182 is a NA study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07397182, a NA study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.
Primary Outcome
Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.
Interventions
- BEHAVIORAL Cognitive BehavioralTherapy for Insomnia (CBT-I)
- BEHAVIORAL SleepSMART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-03-31 |
| Phase | NA |
What is known before NCT07397182 opens enrollment
NCT07397182 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive BehavioralTherapy for Insomnia (CBT-I) is the first listed.
NCT07397182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07397182 about?
NCT07397182 is a clinical study titled "SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment". Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Sympt...
What is the current status of trial NCT07397182?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2026-07-01. Estimated completion is 2030-03-31.
What interventions are being tested in trial NCT07397182?
The interventions under investigation include: Cognitive BehavioralTherapy for Insomnia (CBT-I) (BEHAVIORAL), SleepSMART (BEHAVIORAL).
Who is sponsoring clinical trial NCT07397182?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07397182's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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