The Music, Sleep and Dementia Study
Condition: Dementia; Alzheimer Disease; Circadian Rhythm Disorders; Circadian Rhythm Sleep Disorder; Insomnia; Hypersomnia; Cognitive Impairment; Cognitive Decline; Mild Cognitive Impairment; Frontotemporal Dementia; Neurocognitive Disorders; Vascular Dementia; Sleep Disorder; Memory Impairment
MeSH terms: Alzheimer Disease; Dementia; Sleep Wake Disorders; Parasomnias; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Disorders of Excessive Somnolence; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction; Neurocognitive Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Tailored music listening intervention
Intervention type(s): Behavioral
Intervention description(s): The music intervention consists of listening to preferred soothing music at bedtime for 30 minutes every night for four weeks (28 sessions total). This theory based caregiver-assisted intervention builds on the evidence-based protocol of using individualized music to decrease agitation in nursing home residents. It also accounts for sleep-inducing properties of music.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Wait-list controlled design
Masking: None (Open Label)
Primary purpose: Supportive Care