Skip to main content
Find more clinical trials

Insomnia Therapy for People Living With Dementia and Their Caregivers

Start: June 2020
End: December 2022
Enrollment: 80

What Is This Study About?

Cognitive behavioral therapy for insomnia (CBTi) is a form of talk therapy to improve disturbed sleep. This study will test CBTi to improve the sleep of persons living with dementia (PLWD) and their caregivers who are both experiencing sleep problems. The intervention is designed to improve sleep and health outcomes for PLWD-caregiver pairs. For the four-week CBTi intervention, each PLWD-caregiver pair will receive CBTi via video conferencing sessions. Sleep data, depressive symptoms, and cognitive health data will be collected at the start of the study, and at one week and three months after completion of the intervention.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: N/A

Must have:

Persons Living with Dementia (PLWD) Participants:

  • Caregiver-reported diagnosis of mild cognitive impairment and Alzheimer's disease and related dementias (ADRD)
  • Co-residence with the caregiver in the community
  • Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)

Caregiver Participants:

  • Informal caregiver, for example, a family member or friend, co-residing with the PLWD
  • Providing unpaid assistance, on average 20 hours weekly, for the PLWD participant
  • Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30 minutes more than 3 nights weekly

Both Participants (Caregiver and PLWD):

  • Tolerate and agree to wear wrist actigraph
  • Be able to read, speak, and understand English
  • No vision or hearing problems that would affect study participation 

Must NOT have:

Exclusion Criteria for the PLWD:

  • None

Exclusion Criteria for the Caregivers:

  • Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment 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 that would interfere with following the study protocol

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Glenna Brewster, PhD, RN

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Georgia
Emory University
Atlanta, GA 30322
Recruiting
Goizueta Alzheimer's Disease Research Center
Atlanta, GA 30329
Recruiting

Who Sponsors This Study?

Lead: Emory University

Collaborator Sponsor

  • Alzheimer's Association

Source: ClinicalTrials.gov ID: NCT04426838