Caregivers of Persons With Dementia Clinical Trial
Official title:
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of South Florida | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of South Florida | National Institute on Aging (NIA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total Wake Time (TWT) | 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. |
Week 27-28 | No |
| Primary | Sleep Efficiency (SE) | 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 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. |
Week 27-28 | No |
| Primary | Nighttime Injuries | 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. | Week 27-28 | Yes |
| Secondary | D-Dimer Levels | 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. | Week 27 | No |
| Secondary | Tissue Plasminogen Activator Levels | 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%. | Week 27 | No |
| Secondary | C-reactive Protein (CRP) Levels | 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. | Week 27 | No |
| Secondary | Intercellular Adhesion Molecule-1 (ICAM-1) | 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. | Week 27 | No |
| Secondary | IL-6, and TNFa Levels | 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-a. Levels of IL-6, IL-1, and TNF-a are partially controlled by sleep, and also regulate sleep and many aspects of the immune response. IL-6 and TNF-a 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. | Week 27 | No |