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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Sleep Disturbance
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

Detailed Description

Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Glenna S Brewster, PhD, RN, FNP; Phone Number: (404) 712-9164; Email: glenna.brewster@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Healthcare System
      • Contact: Rashidat Ayantunji; Phone Number: 404-727-9953; Email: rayantu@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for the 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 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 meaningfully in an interview

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for Insomnia (CBTi); Participant dyads will receive CBTi via videoconferencing sessions	Behavioral: 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 Names: CBTi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression	Depression will be measured using the Center for Epidemiologic Studies Depression scale. The Center for Epidemiologic Studies Depression scale has 20 questions. The 20 answers are added up to get a total score between 0 and 60. Total score categories: 16 or greater = Clinically significant depressive symptoms	Baseline, 1-week post-intervention, and 3 months post-intervention
Change in the Quality of Life	Quality of Life will be measured using the research and development (RAND) Medical Outcomes short form (SF)-36. The insomnia severity index has 36 questions which have subscales that total 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 1-week post-intervention, and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Glenna Brewster, PhD, RN, FNP, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Caregivers; Persons living with dementia (PLwD); Cognitive Behavioral Therapy for Insomnia (CBTi)
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyssomnias; Parasomnias; Dementia; Memory Disorders
• Other Study ID Numbers: STUDY00006711; 5K23AG070378-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will share the participants' research identification with instrument responses.
• IPD Sharing Time Frame: Starting 01/01/2028
• IPD Sharing Access Criteria: Requests can be sent to the PI with a document that includes the background and research questions to conduct secondary data analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No