Skip to main content
OpenTrials
Completed

NCT Number: NCT04157244

The Music, Sleep and Dementia Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronobiology Disorders Circadian Rhythm Disorders Circadian Rhythm Sleep Disorder Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Dementia, Vascular Disorders of Excessive Somnolence Dyssomnias Frontotemporal Dementia Frontotemporal Lobar Degeneration Hypersomnia Insomnia Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Memory Disorders Memory Impairment Mental Disorders Metabolic Diseases Mild Cognitive Impairment Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Occupational Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Sleep Disorder Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders TDP-43 Proteinopathies Tauopathies Vascular Dementia Vascular Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Study Measures Completion

    Time frame: Baseline

    Number of participants who complete study measures in accordance with protocol schedule of events

  2. Study Measures Completion

    Time frame: 4 weeks

    Number of participants who complete study measures in accordance with protocol schedule of events

  3. Acceptability of the study components

    Time frame: 4 weeks

    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)

Secondary outcomes

  1. Objective sleep measures

    Time frame: 4 weeks

    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)

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

    Time frame: Baseline and 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.