The Music, Sleep and Dementia Study

NCT04157244 | Completed

• 1 other identifier: 829256
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Objective sleep measures

  4 weeks

• The Quality of Life in Alzheimer's Disease Scale (QOL-AD)

  Baseline and 4 weeks

Study Arms (2)

Experimental: Tailored Music

EXPERIMENTAL

4-week tailored music listening intervention delivered to persons with dementia and their caregivers via a tablet.

Behavioral: Tailored music listening intervention

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)

Interventions

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.

Experimental: Tailored Music

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 20662955 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.

  PMID: 20810376 BACKGROUND

• 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.

  PMID: 37470678 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.

  PMID: 36000763 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Cognitive Dysfunction; Frontotemporal Dementia; Neurocognitive Disorders; Dementia, Vascular; Sleep Wake Disorders; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Dyssomnias; Occupational Diseases; Sleep Disorders, Intrinsic; Cognition Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: Wait-list controlled design

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 8, 2019
• Study Start: March 12, 2019
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)