Clinical trial NCT01550172: Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
Official title: Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of Persons With Dementia
Keywords: dementia caregivers
caregivers
Alzheimer's caregivers
caregiver sleep
heart disease risk
dementia
Alzheimer's Disease
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether a combined intervention of a night home monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in improving sleep in dementia caregivers who arise at night.

Detailed description: Informal caregivers provide the majority of care for chronically ill adults, including persons with dementia. While these individuals provide a great benefit to the chronically ill relative, being a caregiver is associated with deleterious health consequences, including premature mortality and higher rates of coronary heart disease (CHD). Another common complaint among dementia caregivers is poor sleep, which has been connected to premature mortality and higher rates of CHD in noncaregiving adults. Currently no sleep therapies are empirically validated as effective for caregivers of persons with dementia (PWD), and since PWD often arise at night, improving caregiver sleep could be potentially hazardous as a sleeping caregiver cannot provide supervision during night awakenings. Our primary purpose is thus to determine whether a combined intervention is effective in improving sleep in caregivers of PWD who arise at night. The intervention consists of a night home monitoring system that provides reliable alerts to caregivers when PWD leave the bed and move through the house. While this system improved home safety for PWD, it did not affect caregiver sleep, so a more traditional sleep therapy will be added-cognitive-behavioral therapy for insomnia. In the proposed study, experimental participants will receive the night home monitoring system + CBTi; active comparator participants will receive the night home monitoring system and sleep behavioral therapy. Participants will remain in the study for 29 weeks, with 4 data collection points. We hypothesize experimental participants will have less time awake after going to bed, and improved sleep efficiency (percent time asleep while in bed). Sleep data will be collected for multiple nights using actigraphy and sleep diary. Our secondary research questions focus on the relationship between poor sleep and CHD. Both in adults and in dementia caregivers, there appears to be a link between poor sleep and abnormal levels on coronary heart disease biomarkers, and likely an increase in CHD with poor sleep. We aim to further explore this relationship as well as determine whether levels of biomarkers improve with improved sleep from the intervention. We propose to draw blood samples at 4 data collection points and measure a set of biomarkers indicative of CHD.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver for a relative who has been diagnosed by a physician with dementia or Alzheimer's disease.
* Persons with dementia sleep in the same location each night.
* Caregiver provides care for persons with dementia with nighttime activity that occurs at least one night/week.
* Caregiver meets the standard criteria for Insomnia.
* Caregiver sleep problems affect daytime functioning.
* If caregiver uses sleep medication, dose stable for 6 months.
* Caregiver Telephone Interview for Cognitive Status Score \> 25.
* Caregiver does not require assistive devices to walk in the home at night.

Exclusion Criteria:

* Caregiver receives respite care at night the majority of the time.
* Caregiver has diagnosed sleep disorder.
* Caregiver uses CPAP at night
* Caregiver has chronic illness that requires frequent, weekly treatment/assessment by a healthcare provider.
* Current use of anticoagulant medication by the caregiver.
* Caregiver Sleep Apnea-Hypopnea Index (AHI) score \> 10 or \> 15 if pulse oximetry ≥ 88%.
* Caregiver shows evidence of Restless Leg Syndrome per the Cambridge-Hopkins Restless Leg Syndrome Questionnaire.
* Montreal Cognitive Assessment (MOCA) score \< 26.

Primary outcomes:
measure: Total Wake Time (TWT)
timeFrame: Week 27-28
measure: Sleep Efficiency (SE)
timeFrame: Week 27-28
measure: Nighttime Injuries
timeFrame: Week 27-28
Secondary outcomes:
measure: D-Dimer Levels
timeFrame: Week 27
measure: Tissue Plasminogen Activator Levels
timeFrame: Week 27
measure: C-reactive Protein (CRP) Levels
timeFrame: Week 27
measure: Intercellular Adhesion Molecule-1 (ICAM-1)
timeFrame: Week 27
measure: IL-6, and TNFα Levels
timeFrame: Week 27
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Meredeth Rowe, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roth AJ, Curtis AF, Rowe MA, McCrae CS. Using Telehealth to Deliver Cognitive Behavioral Treatment of Insomnia to a Caregiver of a Person With Alzheimer's Disease. J Cogn Psychother. 2022 Feb 1;36(1):3-23. doi: 10.1891/JCPSY-D-20-00055.