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Interventions for Circadian Rhythm Disorders in Dementia (Healthy Patterns Sleep Study)

Recruiting

This Phase III clinical trial will evaluate a 1-month, 8-session program for caregivers that provides instruction in activities to improve symptoms of disturbed sleep-wake cycles in  people with dementia who live at home.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 110 Years All Accepts Healthy Volunteers
May 1, 2016
May 31, 2021
200

Care recipients:

  • Over age 60
  • English speaking
  • Able to tolerate a wristwatch for a month
  • Diagnosis of dementia
  • Symptoms of circadian rhythm disorders, as reported by caregiver
  • If taking any psychotropic medications (antidepressant, benzodiazepine, antipsychotic, or anticonvulsant) or an anti-dementia medication (memantine or cholinesterase inhibitor), on a stable dose for 90 days prior to enrollment

Caregivers:

  • At least 18 years old
  • Living close to the care recipient and planning to stay in the area for at least 6 months
  • If taking a psychotropic medication, on a stable dose for at least 60 days

Care recipients:

  • In a crisis/unsafe situation
  • Planning to move to another residential or care setting within 6 months
  • At end-stage disease (e.g., bed-bound, noncommunicative, on hospice)
  • Currently enrolled in a clinical trial for dementia or associated symptoms
  • Prohibited medications when used regularly: medications with substantial known effects on the measurement of hypothalamic pituitary adrenal (HPA) axis 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 
  • 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, or morbid obesity

Circadian rhythm disorders occur in most people with dementia. Symptoms include late afternoon/evening agitation (e.g., sundowning) and irregular sleep-wake rhythms such as daytime excessive sleepiness, frequent night waking, and poor sleep efficiency. The symptoms of circadian rhythm disorders are associated with increased rates of disease and death and decreased quality of life. Over a 1-month period, participants will receive eight in-home visits and telephone-based sessions from a trainer. Caregivers will be educated on home-based activities to improve the sleep-wake patterns of the care recipients. They will practice each activity under the supervision of the trainer and then on their own. Some participants will be randomized to a control group and receive general education about circadian rhythm disorders. In both groups, the person with dementia will wear a bracelet that measures waking and sleeping time and will be evaluated for neuropsychiatric behaviors.

Name City State Zip Status Primary Contact
University of Pennsylvania
Philadelphia Pennsylvania 19104 Recruiting Sonia Talwar
267-702-6447
HealthyPatternsSleepStudy@gmail.com

University of Pennsylvania

Name Phone Email
Laurel Caffeé 267-702-6447 HealthyPatternsSleepStudy@gmail.com

NCT03682185

The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study