Status:
COMPLETED
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
Lead Sponsor:
Emory University
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Cognitive Impairment
Dementia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological ...
Detailed Description
Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience sleep disturbances, which are distressing for both the PLwD and their caregivers. Specifically, PLwD often e...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the PLwD
- Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and related dementias (ADRD)
- Co-residence with the caregiver in the community
- Montreal Cognitive Assessment (MOCA) score between 12 and 25
- Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days
- Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)
- Inclusion Criteria for the Caregiver
- Informal caregivers (family/friends) of co-residing PLwD
- Providing unpaid assistance, on average 20 hours weekly, for a person in the early stage of illness who is community-dwelling
- Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30 minutes more than 3 nights weekly
- Inclusion Criteria for the Dyad
- Tolerate and agrees to wear wrist actigraph
- Be able to read, speak and understand English
- Have no uncorrectable vision or hearing deficits that might impede participation
- Exclusion Criteria for the PLwD
- None
- Exclusion Criteria for the Caregivers
- Moderate to severe cognitive impairment defined as MoCA score \<17
- Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- Presence of an acute medical or psychiatric condition which would interfere with the subject's ability to realistically follow the study protocol
Exclusion
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04426838
Start Date
September 30 2020
End Date
March 10 2023
Last Update
March 20 2023
Active Locations (2)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, United States, 30329