- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01550172
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep Behavioral Therapy A and NHMS
Participants in this arm receive behavioral therapy A for insomnia and the night home monitoring system.
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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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Week 27-28
|
Sleep Efficiency (SE)
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 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
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Nighttime Injuries
Time Frame: Week 27-28
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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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 27
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Tissue Plasminogen Activator Levels
Time Frame: Week 27
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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
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C-reactive Protein (CRP) Levels
Time Frame: Week 27
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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.
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Week 27
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Intercellular Adhesion Molecule-1 (ICAM-1)
Time Frame: Week 27
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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.
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Week 27
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IL-6, and TNFα Levels
Time Frame: Week 27
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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.
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Week 27
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Meredeth Rowe, RN, PhD, University of South Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6201111800
- 1R01AG039495-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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