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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia (CBTi) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week post-intervention, and 3 months post-intervention

Awards & highlights

SLEEPMATE Trial 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.Check my eligibility

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.See study design

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.

SLEEPMATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

SLEEPMATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week post-intervention, and 3 months post-intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence with Study Interventions (feasibility)

Change in Sleep Efficiency

Change in Wake After Sleep Onset

+3 more

Secondary outcome measures

Change in depression

Change in the Quality of Life

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624

Hematoma R side abdomen

Severe vaginal bleeding and pain

Chest pain in a patient with CAD

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

Antidepressant + Desensitization

Antidepressant + Cognitive Behavioral

SLEEPMATE 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

~1800

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,805 Total Patients Enrolled

268 Trials studying Dementia

23,627,526 Patients Enrolled for Dementia

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,577 Total Patients Enrolled

20 Trials studying Dementia

2,756 Patients Enrolled for Dementia

Glenna Brewster, PhD, RN, FNPPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"As per clinicaltrials.gov, this particular medical investigation is not actively seeking participants. The trial was originally published on February 1st, 2024 and last updated on the same date. While recruitment is currently closed for this study, it's worth noting that there are 543 alternative trials presently accepting patients for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners

Glenna Brewster 2024. "Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06250725.

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