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Clinical Trial Summary

The specific aims of this studyare to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with dementia suffering from sleep disruption. Sixty dyads (older adults with dementia and their caregivers) will be randomized to receive the tailored music intervention immediately or following a four week delay.


Clinical Trial Description

Sleep disruption in older adults living with Alzheimer's disease and related dementias (ADRD) is very debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Furthermore, sleep disruption is linked to poor health outcomes in caregivers (CGs), such as poor quality of life and increased CG burden. Given the potential harmful side effects of pharmacologic treatment, non-pharmacologic approaches, such as music, may provide a safer alternative to reducing sleep disruption in this vulnerable population. Listening to music has been shown to decrease agitation, anxiety and depression in nursing home residents with ADRD. A growing body of literature suggests that individualized music may improve sleep quality in older adults with early memory loss, but its efficacy has not been demonstrated in older adults with ADRD in the community, where most older adults with ADRD live. If proven feasible and acceptable, tailored music interventions can then be tested for efficacy in reducing sleep disruption. Music selections will be individualized to older adults with ADRD and account for known sleep-inducing properties. Feasibility of processes that are key to the success of the subsequent study will be examined. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective (proxy reported) sleep quality measures. In addition, qualitative data will be solicited from the dyads examining the acceptability and satisfaction with the intervention. ;


Study Design


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 NCT04157244
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date March 12, 2019
Completion date January 12, 2021

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