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

NCT06250725 | Recruiting

• 3 other identifiers: STUDY000067115K23AG070378-032025P009764
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

Conditions

Sleep Disturbance; Dementia

Keywords

Persons living with dementia (PLwD); Caregivers; Cognitive Behavioral Therapy for Insomnia (CBTi)

Outcome Measures

Primary Outcomes (6)

• Change in insomnia

  Insomnia will be measured using the Insomnia Severity Index. The insomnia severity index ahs seven questions. The seven answers are added up to get a total score. Total score categories: 0-7= No clinically significant insomnia 8-14= Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) 22-28= Clinical insomnia (Severe)

  Baseline, 1-week post-intervention, and 3 months post-intervention

• Change in Sleep Efficiency

  Sleep Efficiency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.

  Baseline, 1-week post-intervention, and 3 months post-intervention

• Change in in Sleep Onset Latency

  Sleep onset latency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.

  Baseline, 1-week post-intervention, and 3 months post-intervention

• Change in Wake After Sleep Onset

  Wake after sleep onset will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.

  Baseline, 1-week post-intervention, and 3 months post-intervention

• Adherence with Study Interventions (feasibility)

  Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation.

  weekly during the intervention period up to 3 months post-intervention

• Satisfaction with intervention components

  Satisfaction with the intervention components will be assessed with the study satisfaction measure questionnaire that has 16 questions type that uses an agree, disagree scale as a range of answer options that go from strongly agree to strongly disagree.

  1 week post-intervention

Secondary Outcomes (2)

• Change in depression

  Baseline, 1-week post-intervention, and 3 months post-intervention

• Change in the Quality of Life

  Baseline, 1-week post-intervention, and 3 months post-intervention

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia (CBTi)

EXPERIMENTAL

Participant dyads will receive CBTi via videoconferencing sessions

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: CBTi

Cognitive Behavioral Therapy for Insomnia (CBTi)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥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

You may not qualify if:

• PLwCI: Moderate to severe cognitive impairment
• Individuals who are not yet adults
• Pregnant women
• Prisoners
• Individuals who are not able to clearly understand English.

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory Healthcare System

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Dementia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Glenna Brewster, PhD, RN, FNP

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenna S Brewster, PhD, RN, FNP

CONTACT

(404) 712-9164; glenna.brewster@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 01/01/2028
• Access Criteria: Requests can be sent to the PI with a document that includes the background and research questions to conduct secondary data analyses.

Locations

US (1)