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New sleep program aims to ease insomnia in dementia patients and caregivers

NCT ID NCT06250725

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a 6-week videoconference program that teaches sleep-improving skills to older adults with memory loss or dementia and their care partners. About 80 participants will join either individually or together. The goal is to see if the program is practical, acceptable, and helpful for reducing insomnia and improving sleep quality.

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 80 people

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

Started

Aug 2024

Expected to finish

Sep 2026

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

Accepted

You do not need to have the condition being studied to take part.

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 for the PLwCI: * Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or * Montreal Cognitive Assessment (MOCA) score between 12 and 24; * Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale; * Have an eligible caregiver; * Be able to participate in the intervention sessions Inclusion Criteria for Caregivers: * ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI); * Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or * ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months; * Have difficulty falling asleep or difficulty staying asleep for the last three months or * Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater Exclusion Criteria: * PLwCI: Moderate to severe 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.

dementia Parasomnias sleep disorder

As listed by the trial registrant

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

Dementia Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory Healthcare System

    RECRUITING

    Atlanta, Georgia, 30322, United States

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