The Healthy Patterns Sleep Study

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    200
  • sponsor
    University of Pennsylvania
Updated on 24 January 2021
antidepressant
benzodiazepines
dementia
convulsant
antidepressants
antipsychotics
psychotropic drugs
memantine
cholinesterase inhibitors
cholinesterase
polysomnography
actigraphy
antipsychotic
psychotropic
cholinesterase inhibitor
psychoactive agents
antipsychotic agents
psychotherapeutic

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.

Description

Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and fatal neurodegenerative condition, affecting close to 15 million family caregivers (CG). Circadian rhythm disorders (CRDs) occur in the majority of persons with dementia and include late afternoon/evening agitation (e.g. sundowning) and irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. CRDs can cause a specific cluster of neuropsychiatric symptoms that occur in over 60 percent of patients with dementia and are associated with increased morbidity and mortality and decreased quality of life. Regulating the circadian system via different types of activity have been shown to alter core clock processes that drive CRD symptoms and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism to reduce neuropsychiatric symptoms, decrease sleep disruptions, and enhance quality of life for both the care receiver and the caregiver.

Specific components of this brief, one-month, eight sessions, home-based intervention include: 1) assessing PWD health/functional status and preferences/interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training of caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day.

Details
Condition Circadian Rhythm Sleep Disorder, Frontotemporal Dementia, Pick's Disease, Circadian Dysregulation, Vascular Dementia, Insomnia, Hypersomnia, Dementia, Memory impairment, Alzheimer's Disease, Sleep Disorders, Sleep Disorders (Pediatric), Mild Cognitive Impairment, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline, Neurocognitive Disorders, Neurocognitive Disorder, Cognitive Impairments, Mild Neurocognitive Disorder, Mental Deterioration, Memory Problems, sleep disorder, excessive sleepiness, impair memory, bad memory, disturbance of memory, neurocognitive disturbance, dementia, frontotemporal, alzheimer, dementia alzheimer's type
Treatment Attention-Control Condition, Timed Activity Intervention
Clinical Study IdentifierNCT03682185
SponsorUniversity of Pennsylvania
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 110 yrs?
Gender: Male or Female
Do you have any of these conditions: Dementia or Alzheimer's Disease or Cognitive Decline or Circadian Rhythm Sleep Disorder or Memory impairment or Vascular Dementia or Hypersomnia or Co...?
Do you have any of these conditions: Circadian Rhythm Sleep Disorder or Alzheimer's Disease or Mental Deterioration or Sleep Disorders or Dementia or Mild Neurocognitive Disorder or Cogni...?
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

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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