The Music, Sleep and Dementia Study

Alzheimer Disease Clinical Trial

Official title:

The Feasibility of a Tailored Music Intervention to Reduce Symptoms of Sleep Disruption in Older Adults With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157244
• Other study ID #: 829256
• Status: Completed
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: January 12, 2021

Study information

• Verified date: January 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Chronobiology Disorders
• Circadian Rhythm Disorders
• Circadian Rhythm Sleep Disorder
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Vascular
• Disease
• Disorders of Excessive Somnolence
• Frontotemporal Dementia
• Hypersomnia
• Insomnia
• Memory Impairment
• Mild Cognitive Impairment
• Neurocognitive Disorders
• Parasomnias
• Pick Disease of the Brain
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Vascular Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Measures Completion	Number of participants who complete study measures in accordance with protocol schedule of events	Baseline
Primary	Study Measures Completion	Number of participants who complete study measures in accordance with protocol schedule of events	4 weeks
Primary	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
Secondary	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)	4 weeks
Secondary	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