Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers



Status:Recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:April 2012
End Date:December 2017
Contact:Margaret Gross-King, MSN
Email:megross@health.usf.edu
Phone:1-813-974-1827

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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.

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.

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.
We found this trial at
1
site
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Meredeth Rowe, RN, PhD
Phone: 813-974-1827
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