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Behavioral Intervention

Sleep Therapy for Dementia (SLEEPMATE Trial)

N/A
Recruiting
Led By Glenna Brewster, PhD, RN, FNP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PLwCI: Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment based on electronic medical records or prescribed medications
Caregivers: 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
Must not have
PLwCI: Individuals who are not yet adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week post-intervention, and 3 months post-intervention
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if a 6-week online program can effectively teach skills to improve sleep for individuals with memory loss, cognitive impairment, or dementia, as well as their caregivers."

Who is the study for?
This trial is for older adults experiencing memory loss, cognitive impairment, or dementia and their care partners. They should be willing to participate in a 6-week videoconference program aimed at improving sleep.
What is being tested?
The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I), delivered through videoconferencing over six weeks, can improve sleep quality for those with memory issues and their caregivers.
What are the potential side effects?
Since the intervention involves therapy rather than medication, side effects are minimal but may include temporary increases in anxiety or stress due to changes in sleep habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's or a related dementia, or I am showing signs of cognitive impairment.
Select...
I have been helping someone with their daily or instrumental activities for the past 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under the age of 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week post-intervention, and 3 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-intervention, and 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence with Study Interventions (feasibility)
Change in Sleep Efficiency
Change in Wake After Sleep Onset
+3 more
Secondary study objectives
Change in depression
Change in the Quality of Life

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral Therapy for Insomnia (CBTi)Experimental Treatment1 Intervention
Participant dyads will receive CBTi via videoconferencing sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,656 Total Patients Enrolled
292 Trials studying Dementia
23,634,793 Patients Enrolled for Dementia
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,838 Total Patients Enrolled
23 Trials studying Dementia
2,972 Patients Enrolled for Dementia
Glenna Brewster, PhD, RN, FNPPrincipal InvestigatorEmory University
~53 spots leftby Jan 2026