Clinical trial NCT04157244: The Music, Sleep and Dementia Study
Official title: The Feasibility of a Tailored Music Intervention to Reduce Symptoms of Sleep Disruption in Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list controlled design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Study Measures Completion
timeFrame: Baseline
measure: Study Measures Completion
timeFrame: 4 weeks
measure: Acceptability of the study components
timeFrame: 4 weeks
Secondary outcomes:
measure: Objective sleep measures
timeFrame: 4 weeks
measure: The Quality of Life in Alzheimer's Disease Scale (QOL-AD)
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.