The Music, Sleep and Dementia Study

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04157244

Run by

University of Pennsylvania

People needed

32

Starts

2019-03-12

Expected to finish

2021-01-12

Last updated by the study team

2021-01-13

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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