The Healthy Patterns Sleep Study

Alzheimer Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Chronobiology Disorders
• Circadian Rhythm Disorders
• Circadian Rhythm Sleep Disorder
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Vascular
• Disease
• Disorders of Excessive Somnolence
• Frontotemporal Dementia
• Hypersomnia
• Insomnia
• Memory Impairment
• Mild Cognitive Impairment
• Neurocognitive Disorders
• Parasomnias
• Pick Disease of the Brain
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Vascular Dementia

• NCT number: NCT03682185
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2016
• Completion date: May 31, 2021