The Healthy Patterns Sleep Study (NCT03682185) | Clinical Trial Compass
CompletedPhase 3
The Healthy Patterns Sleep Study
United States421 participantsStarted 2016-05-01
Plain-language summary
The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.
Who can participate
Age range18 Years – 110 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. be over age 60
✓. English speaking
✓. be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
✓. diagnosed with dementia using standard assessments and diagnostic criteria
✓. has CG reporting the presence of CRD symptoms
✓. If the CR is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that the CR have been on a stable dose for 90 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications
✓. CG is at least 18 years old
✓. CG lives close to the participant
Exclusion criteria
✕. deemed to be in a crisis/unsafe situation at baseline
✕. reported planned transition to another residential or care setting in less than 6 months
✕. at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
✕. currently enrolled in an interventional clinical trial for dementia or associated symptoms
What they're measuring
1
Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale
. regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
✕. major surgery in the past 3 months
✕. history of major psychiatric and/or personality disorder
✕. history of heavy cigarette smoking (e.g. than 50 pack years)