Phase 3
N=421
The Healthy Patterns Sleep Study
Dementia · Alzheimer Disease · Circadian Rhythm Disorders · Circadian Rhythm Sleep Disorder · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03682185 ↗Enrolled (actual)
421
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale — 0.56; -0.47 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Attention-Control Condition (Behavioral); Timed Activity Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale |
0.56; -0.47 | — |
| SECONDARY Neuropsychiatric Inventory (NPI) |
— | — |
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.
Eligibility Criteria
Inclusion criteria for care receiver (CR):
- 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
Inclusion criteria for caregiver (CG):
- CG is at least 18 years old
- CG lives close to the participant
- CG is planning to live in the area for at least 6 months
- If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days
Exclusion criteria for CR:
- 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
- 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)
- loss of a loved one in the past 3 months
- conditions known to affect measurement of circadian rhythm such as use of sedatives/ hypnotics, Huntington's disease, Cushing's disease, Addison's disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI 35)
Data sourced from ClinicalTrials.gov (NCT03682185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.