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NCT05565833 · ClinicalTrials.gov registry record · Phase 2
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
A Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT05565833: Recruiting Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of Virginia.
NCT05565833 is a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 144 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05565833, a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.
Primary Outcome
Change in overall insomnia severity
Conditions Studied
Interventions
- BEHAVIORAL SHUTi OASIS
- OTHER Patient Education
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2023-02-27 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What NCT05565833 shows while recruiting
NCT05565833 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower).
The record links to 9 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which SHUTi OASIS is the first listed.
NCT05565833 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05565833 about?
NCT05565833 is a clinical study titled "Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)". This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the...
What is the current status of trial NCT05565833?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2023-02-27. Estimated completion is 2028-01.
What conditions does trial NCT05565833 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Insomnia, Cognitive Dysfunction, Nervous System Diseases.
What interventions are being tested in trial NCT05565833?
The interventions under investigation include: SHUTi OASIS (BEHAVIORAL), Patient Education (OTHER).
Who is sponsoring clinical trial NCT05565833?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05565833 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05565833's enrollment target sits among peer trials
144 133rd of 306 higher than 173 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
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