Alzheimer's Disease Education and Referral Center

Improving Dementia Caregiver Sleep and the Effect on Heart Disease Biomarkers

Improving Dementia Caregiver Sleep and the Effect on Heart Disease Biomarkers

Overall Status: 
Brief Description: 

The purpose of the study is to determine whether a nighttime home monitoring system combined with cognitive-behavioral therapy for insomnia is effective in improving sleep in dementia caregivers who arise at night.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
21 Years
Inclusion Criteria: 

  • Primary caregiver for a relative who has been diagnosed with Alzheimer's disease or another dementia
  • People with dementia sleep in the same location each night
  • Nighttime activity occurs at least one night per week
  • Caregiver meets the standard criteria for insomnia
  • Caregiver sleep problems affect daytime functioning
  • If caregiver uses sleep medication, on dose stable for at least 6 months
  • Normal cognition for caregiver
  • Caregiver does not require assistive devices to walk in the home at night

Exclusion Criteria: 

  • Caregiver receives respite care at night most of the time
  • Caregiver has diagnosed sleep disorder or uses continuous positive airway pressure (CPAP) at night
  • Caregiver has chronic illness that requires frequent treatment/assessment
  • Current use of anticoagulant medication by caregiver
  • Caregiver shows evidence of Restless Leg Syndrome
  • Montreal Cognitive Assessment (MOCA) score of less than 26

Detailed Description: 

Caregivers of people with dementia commonly complain about poor sleep, which has been connected to early death and higher rates of coronary heart disease (CHD). Currently, no sleep therapies have been proven effective for caregivers of people with dementia. Since people with dementia often arise at night, improving caregiver sleep could be potentially hazardous, as a sleeping caregiver cannot provide supervision during night awakenings.

This study's primary purpose is to determine whether a nighttime home monitoring system combined with cognitive-behavioral therapy for insomnia will improve sleep for dementia caregivers. The monitoring system alerts to caregivers when people with dementia leave the bed and move through the house. Participants receiving the intervention will be compared with those who receive the nighttime home monitoring system and sleep behavioral therapy. Participants will remain in the study for 29 weeks.

We hypothesize that experimental participants will have less time awake after going to bed and improved sleep efficiency (percentage of time asleep while in bed). Sleep data will be collected for multiple nights using a sleep diary and actigraphy, a noninvasive method of monitoring human rest and activity cycles.

Our secondary research focuses on the relationship between poor sleep and CHD. We aim to further explore this relationship and to determine whether levels of CHD biomarkers improve with improved sleep from the intervention.

Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 28.0563834, -82.4427769

Name: Margaret Gross-King, RN, MS
Phone: 813-974-1827
Lead Sponsor: 
University of South Florida
Collaborator Sponsor: 
National Institute on Aging (NIA)
Facility Investigators: 
Meredeth Rowe, RN, PhD
Principal Investigator
University of South Florida
Study Contact: 
Brandi Mallek
Locations ID 
NCT01550172 (follow link to view full record on in new window)
Official Title: 
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
Study Start Date: 
April 2012
Study End Date: 
July 2016