Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
|Caregivers of Persons With Dementia||Behavioral: Sleep Behavioral Therapy A and NHMS Behavioral: Sleep Behavioral Therapy B and NHMS|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers|
- Total Wake Time (TWT) [ Time Frame: Week 27-28 ]
Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability.
Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of TWT. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
- Sleep Efficiency (SE) [ Time Frame: Week 27-28 ]
Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of SE. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating.
- Nighttime Injuries [ Time Frame: Week 27-28 ]The Caregiver will be asked about any PWD injuries that occurred since the last data collection point. Injuries will be coded according to the American National Standards method of recording injuries. The following data are collected: nature of injury; part of the body affected; object, substance, exposure, or bodily motion that caused the injury; event that directly resulted in the injury; and time and place of the injury's occurrence. An injury will be considered nighttime if the caregiver reported being asleep at the time the injury occurred.
- D-Dimer Levels [ Time Frame: Week 27 ]D-Dimer is a marker of coagulation activation and has been associated with coronary events. It has also been inversely associated with wake after sleep onset as well as poor sleep quality and low sleep efficiency. D-dimer is a byproduct of fibrinolysis which remains after a blood clot has been degraded. It consists of two cross linked fragments of fibrinogen. Elevated levels of D-dimer are a marker of thrombosis, as it might occur along atherosclerotic plaques in coronary blood vessels. D-dimer will be measured by monoclonal sandwich ELISA, which measures in the 3.9 - 250 ng/ml range.
- Tissue Plasminogen Activator Levels [ Time Frame: Week 27 ]Tissue Plasminogen Activator is an endothelial lining protein that catalyzes the conversion of plasminogen into plasmin, which is responsible for the degradation of fibrin into soluble degradation products. Caregivers of PWD showed higher levels of TPA. A meta-analysis of cardiovascular disease risk and TPA indicated that levels greater than 13.5 ng/ml increased CVD risk by 50%.
- C-reactive Protein (CRP) Levels [ Time Frame: Week 27 ]C-reactive protein (CRP) is a non-specific marker of inflammation shown in many studies to be elevated in AD caregivers and to be associated with poor sleep. High sensitivity CRP levels are consistently and independently associated with increased risk of cardiovascular events. HS-CRP will be measured by an ELISA.
- Intercellular Adhesion Molecule-1 (ICAM-1) [ Time Frame: Week 27 ]Intercellular adhesion molecule-1 (ICAM-1) is found in leukocytes and endothelium and is involved in adhesion of leukocytes to and through the endothelium. ICAM-1 is stimulated by the proinflammatory cytokines. ICAM-1 may participate in atherogenesis by increasing monocyte transmigration into the arterial intima.
- IL-6, and TNFα Levels [ Time Frame: Week 27 ]It is becoming apparent that sleep and immunity are strongly related and that impairments in sleep increase these circulating cytokine levels. Further, caregivers of Alzheimer's patients show both impaired sleep and elevated IL-6 and TNF-α. Levels of IL-6, IL-1, and TNF-α are partially controlled by sleep, and also regulate sleep and many aspects of the immune response. IL-6 and TNF-α are central mediators in the inflammatory process by regulating acute phase and coagulation protein, and inflammation plays a central role in the development and instability of atherosclerotic plaques.
|Study Start Date:||April 2012|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Sleep Behavioral Therapy A and NHMS
Participants in this arm receive behavioral therapy A for insomnia and the night home monitoring system.
Behavioral: Sleep Behavioral Therapy A and NHMS
The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments.
Active Comparator: Sleep Behavioral Therapy B and NHMS
Participants in this arm receive sleep behavioral therapy B and the night home monitoring system.
Behavioral: Sleep Behavioral Therapy B and NHMS
The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
Sleep behavioral therapy B uses primarily behavioral adjustments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550172
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Meredeth Rowe, RN, PhD||University of South Florida|