The Music, Sleep and Dementia Study

Not Applicable

Completed

• Conditions: Dementia; Hypersomnia; Cognitive Decline; Insomnia; Cognitive Impairment; Mild Cognitive Impairment; Alzheimer Disease; Circadian Rhythm Disorders; Frontotemporal Dementia; Neurocognitive Disorders
• Interventions: Behavioral: Tailored music listening intervention

• Registration Number: NCT04157244
• Lead Sponsor: University of Pennsylvania

Brief 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.

Study Timeline

• Study Start: 2019-03-12
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Status Verified: 2021-01
• Primary Completion: 2021-01-12
• Study Completion: 2021-01-12
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Tailored Music	Tailored music listening intervention	4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet.

Primary Outcome Measures

Name	Time	Method
Study Measures Completion	4 weeks	Number of participants who complete study measures in accordance with protocol schedule of events
Acceptability of the study components	4 weeks	Two questions from a survey developed by Gitlin and colleagues (2010) which examines satisfaction with participation and perceived benefits.; The survey uses a scale of 1-3 (1- Not at all to 3-A great deal) to rate caregiver perceived 1) overall benefit from participating in the study and 2) improvement in life of person's with dementia.; Min score 2, maximum score 6 (with higher scores indicating greater satisfaction and perceived benefits)

Secondary Outcome Measures

Name	Time	Method
The Quality of Life in Alzheimer's Disease Scale (QOL-AD)	Baseline and 4 weeks	Person with dementia quality of life. The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks.
Objective sleep measures	4 weeks	Measured using an actigraphy bracelet worn by person with dementia for consecutive 24-hour periods for 4 weeks. The actigraph will measure: 1) Sleep latency (Time it takes a person to fall asleep starting from first intention to sleep); 2) Wake after sleep onset (Time awake during the night, beginning from the time person falls asleep); 3) Total sleep duration (Actual time person is asleep)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States