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

Dementia Clinical Trial

— SLEEPMATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250725
• Other study ID #: STUDY00006711
• Secondary ID: 5K23AG070378-03
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: Glenna S Brewster, PhD, RN, FNP
• Phone: (404) 712-9164
• Email: glenna.brewster[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Memory Disorders
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Healthcare System	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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