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Can a 5-Week online sleep program help dementia patients and their caregivers rest better?

NCT ID NCT07572565

Symptom relief Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a virtual cognitive behavioral therapy for insomnia (CBT-I) program, called REPAIR Sleep, can improve sleep and emotional well-being in people with dementia and their live-in caregivers. Over 5 weekly video sessions, participants learn techniques like setting consistent wake times, relaxing before bed, and changing unhelpful sleep thoughts. The trial will compare this program to a healthy living education group, tracking sleep diaries, actigraphy, and mood for 9 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy for insomnia (CBT-I) delivered via videoconferencing
What this could lead to
If it works, this could offer a practical, non-drug way to improve sleep and reduce stress for both people with dementia and their caregivers.
What could go wrong
This is a relatively small early-stage trial (120 participants) testing a behavioral intervention, so results may not apply to everyone. Success depends on participants sticking with the program, and sleep improvements may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: PLwCC and Caregiver * Have Insomnia Severity Index (ISI) ≥10 * Have difficulty initiating or maintaining sleep or waking up too early at least three nights per week * Have sleep disturbances persisting for at least three months * Have daytime impairment (e.g., fatigue, mood disturbance) * Community-dwelling * Co-residing with each other * Have internet access * No history of surgery in the past 4 weeks Caregivers -Regularly assist the care recipient with ≥1 of 7 basic activities of daily living61 or ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months. PLwD -Reported or diagnosed cognitive impairment; able to complete simple directives. Exclusion Criteria: PLwCC or Caregiver: * A diagnosis of psychosis, major depressive disorder, or bipolar disorder that is not currently treated; * Having had substance or alcohol dependency, or active suicidality in the past year * Currently have narcolepsy or restless leg syndrome * Does shift work * Plan trans-meridian travel during the period of data collection blocks * Hearing or visual impairment Caregivers * Dementia or cognitive impairment. * Individuals who are not yet adults * Pregnant women * Prisoners * Individuals who are not able to clearly understand English.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognition Disorders cognitive disorder dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Cognition disorder

How to take part

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  1. The official record

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