Clinical Trial

Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

Recruiting Phase 2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-09-29; most recent amendment 2024-05-06.
Status change: Not Yet Recruiting → Recruiting 2023-02-28
Trial Details
NCT Number NCT05565833
Lead Sponsor University of Virginia
Conditions Insomnia, Cognitive Dysfunction, Mild Cognitive Impairment, Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases +1 more
Enrollment 144 participants
Start Date 2023-02-27
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2024-05-08