Clinical trial NCT06250725: Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
Official title: Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Dementia
Keywords: Persons living with dementia (PLwD)
Caregivers
Cognitive Behavioral Therapy for Insomnia (CBTi)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in insomnia
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
measure: Change in Sleep Efficiency
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
measure: Change in in Sleep Onset Latency
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
measure: Change in Wake After Sleep Onset
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
measure: Adherence with Study Interventions (feasibility)
timeFrame: weekly during the intervention period up to 3 months post-intervention
measure: Satisfaction with intervention components
timeFrame: 1 week post-intervention
Secondary outcomes:
measure: Change in depression
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
measure: Change in the Quality of Life
timeFrame: Baseline, 1-week post-intervention, and 3 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
Study officials:
affiliation: Emory University
name: Glenna Brewster, PhD, RN, FNP
role: PRINCIPAL_INVESTIGATOR
References: