Mode
Text Size
Log in / Sign up
Phase 3 N=421 Randomized Single-blind Supportive Care

The Healthy Patterns Sleep Study

Dementia · Alzheimer Disease · Circadian Rhythm Disorders · Circadian Rhythm Sleep Disorder · Insomnia

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

Back to search