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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Tailored Music | Experimental | 4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet. |
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| 4-week Wait-list control | No Intervention | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored music listening intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Measures Completion | Number of participants who complete study measures in accordance with protocol schedule of events | Baseline |
| Study Measures Completion | Number of participants who complete study measures in accordance with protocol schedule of events | 4 weeks |
| Acceptability of the study components | 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective sleep measures | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20662955 | Background | 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. | |
| 20810376 | Background | 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. |
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Wait-list controlled design
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| 4 weeks |
| The Quality of Life in Alzheimer's Disease Scale (QOL-AD) | 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. | Baseline and 4 weeks |
| 37470678 | Derived | 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. |
| 36000763 | Derived | 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. |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D021081 | Chronobiology Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006970 | Disorders of Excessive Somnolence |
| D060825 | Cognitive Dysfunction |
| D057180 | Frontotemporal Dementia |
| D019965 | Neurocognitive Disorders |
| D015140 | Dementia, Vascular |
| D012893 | Sleep Wake Disorders |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D020920 | Dyssomnias |
| D009784 | Occupational Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D003072 | Cognition Disorders |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
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