Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
NCT ID: NCT06250725
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-08-01
2026-01-31
Brief Summary
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Detailed Description
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There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cognitive Behavioral Therapy for Insomnia (CBTi)
Participant dyads will receive CBTi via videoconferencing sessions
Cognitive Behavioral Therapy for Insomnia
The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.
Interventions
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Cognitive Behavioral Therapy for Insomnia
The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* ≥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
* Individuals who are not yet adults
* Pregnant women
* Prisoners
* Individuals who are not able to clearly understand English.
18 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Emory University
OTHER
Responsible Party
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Glenna Brewster
Assistant Professor
Principal Investigators
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Glenna Brewster, PhD, RN, FNP
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Healthcare System
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00006711
Identifier Type: -
Identifier Source: org_study_id
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