The Impact of Music Intervention on Sleep

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-08-31

Brief Summary

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The primary purpose of this Stage 1b NIH-funded clinical trial (K23AG073618, PI Petrovsky) is to determine the efficacy of a 1-month music intervention (Calming Music Personalized for Sleep Enhancement in PeRsons living with Dementia, CoMPoSER) on health outcomes in 72 dyads (144 participants) of persons living with dementia (PLWD) and their caregivers (Stage 1b). The secondary purpose of this research project is to examine the mechanism of stress reduction and sustained effects of the music intervention on PLWD and caregiver well-being. We will evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT and determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

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Detailed Description

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Aim 1: Evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT.

Aim 2: Determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

Aim 3: Examine stress reduction as a mechanism of action measured via salivary cortisol by which 1-month long CoMPoSER intervention affects insomnia symptoms in PLWD.

Aim 4: To determine the sustained (3 months) efficacy of CoMPoSER compared to control group on PLWD and caregiver health outcomes.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will consist of 144 participants (72 dyads). Dyads will receive 4 weekly phone calls in addition to the baseline and post-intervention in-person home visits. Those receiving the CoMPoSER intervention will undergo the following components: A) relaxation techniques; B) meaningful and relaxing music playlist, tailored to PLWD preferred genre, and C) nighttime routine guidance. Those undergoing the attention control intervention will receive sleep education. The attention control design includes participants finding their own treatment if assigned to no-treatment group and higher study dropout rates.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sleep Education Group

Participants in this group will receive sleep education.

Group Type ACTIVE_COMPARATOR

Sleep Education

Intervention Type OTHER

Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.

CoMPoSER Intervention Group

Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement.

Group Type EXPERIMENTAL

CoMPoSER intervention group

Intervention Type OTHER

Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.

Interventions

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CoMPoSER intervention group

Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.

Intervention Type OTHER

Sleep Education

Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 60 and above
* Existing physician diagnosis of dementia or self-reported memory impairment and Clinical Dementia Rating Scale score of greater than 0.5,
* Score of \>10 on the Insomnia Severity Index
* Stable dose of psychotropic medications
* Agreeing to wear an actiwatch for the duration of the study

* Age 18 and above.
* Providing at least 4 hours of daily care
* Living with PLWD
* Able to read and communicate in English

Exclusion Criteria

* Hearing impairment
* Planned transition to a residential or institutional care facility in 3 months
* Presence of extrapyramidal symptoms or acute sleep disruption
* Bed bound
* Living in an alternative home setting (such as Assisted Living Community)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes