Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2019-03-12
2021-01-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental: Tailored Music
4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet.
Tailored music listening intervention
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.
4-week Wait-list control
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)
No interventions assigned to this group
Interventions
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Tailored music listening intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
110 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Darina Petrovsky, PhD, RN
Postdoctoral Research Fellow
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. Targeting and managing behavioral symptoms in individuals with dementia: a randomized trial of a nonpharmacological intervention. J Am Geriatr Soc. 2010 Aug;58(8):1465-74. doi: 10.1111/j.1532-5415.2010.02971.x. Epub 2010 Jul 19.
Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. JAMA. 2010 Sep 1;304(9):983-91. doi: 10.1001/jama.2010.1253.
Petrovsky DV, Bradt J, McPhillips MV, Sefcik JS, Gitlin LN, Hodgson NA. Tailored Music Listening in Persons With Dementia: A Feasibility Randomized Clinical Trial. Am J Alzheimers Dis Other Demen. 2023 Jan-Dec;38:15333175231186728. doi: 10.1177/15333175231186728.
Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.
Other Identifiers
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829256
Identifier Type: -
Identifier Source: org_study_id
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