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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 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.

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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.

Conditions Studied

Alzheimer Disease Mild Cognitive Impairment Insomnia Cognitive Dysfunction Nervous System Diseases Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Dyssomnias Sleep Disorders, Intrinsic

Interventions

  • BEHAVIORAL SHUTi OASIS
  • OTHER Patient Education

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2023-02-27
Est. Completion 2028-01
Phase Phase 2

Sponsor

University of Virginia

449 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05565833

The ClinicalTrials.gov registry entry for NCT05565833 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.