The Music, Sleep and Dementia Study

University of Pennsylvania

Status: Completed

Conditions: Cognitive Impairment; Circadian Rhythm Sleep Disorder; Cognitive Decline; Insomnia; Memory Impairment; Neurocognitive Disorders; Hypersomnia; Alzheimer Disease; Frontotemporal Dementia; Mild Cognitive Impairment; Sleep Disorder; Vascular Dementia; Circadian Rhythm Disorders; Dementia

Treatments: Behavioral: Tailored music listening intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04157244

829256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 60 and older
• Physician diagnosis of probable ADRD using standard assessments and diagnostic criteria
• Presence of sleep problems determined first during phone screening using NPI sleep disorders item, then using proxy-rated Sleep Disorders Inventory (SDI) (presence of at least one sleep disturbance symptom of moderate severity)
• Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia or opioids in the past 90 days (typical time frame in clinical trials) prior to enrollment to minimize confounding effects of medications
• Tolerates and agrees to wear wrist actigraph
• Responsive to their environment (e.g., able to understand short commands)
• Sufficient English to complete questionnaires

Exclusion criteria

• Planned transition to another residential or institutional care setting in less than 3 months
• Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet)
• Presence of extrapyramidal symptoms affecting non-dominant hand which may include persons with the following diagnoses: schizophrenia, bipolar disorder, Huntington's disease, Parkinson's disease, Lewy Body dementia due to REM sleep disorders
• Currently enrolled in an interventional clinical trial for ADRD aimed to improve sleep
• Acute sleep disruption within 2 weeks of screening as it may indicate sleep disorders not related to ADRD or delirium
• End stage disease (i.e. cancer, bed bound)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Experimental: Tailored Music

Experimental group

Description:

4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet.

Treatment:

Behavioral: Tailored music listening intervention

4-week Wait-list control

No Intervention group

Description:

4-week wait-list control (Note: participants will be crossed over to 4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet)