The Impact of Music Intervention on Sleep
August 24, 2026 updated by: Duke University
The Impact of Music Intervention on Sleep: CoMPoSER Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darina Petrovsky
- Phone Number: 919-684-3786
- Email: darina.petrovsky@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University School of Nursing
-
Contact:
- Darina Petrovsky
- Phone Number: 9196817041
- Email: PetrovskyResearch@duke.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria for persons living with dementia (PLWD):
- 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
PLWD 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)
Informal caregivers inclusion criteria:
- Age 18 and above.
- Providing at least 4 hours of daily care
- Living with PLWD
- Able to read and communicate in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sleep Education Group
Participants in this group will receive 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.
|
|
Experimental: CoMPoSER Intervention Group
Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement.
|
Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 4 weeks
|
At least 80% of the dyads will find the intervention acceptable
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PLWD Objective Sleep Outcomes
Time Frame: 1 month, 3 months
|
Compared to PLWD in the sleep education control group, PLWD in the CoMPoSER intervention will experience improved insomnia symptoms of sleep latency, sleep efficiency, wake after sleep onset, total sleep time measured via sleep diary and actigraphy.
|
1 month, 3 months
|
|
PLWD Subjective Sleep Outcomes
Time Frame: 1 month, 3 months
|
Compared to PLWD in the sleep education control group, PLWD in the CoMPoSER intervention will experience improved sleep quality via self-report.
The Pittsburgh Sleep Quality Index (PSQI) will be used to measure sleep quality.
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).
The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.
|
1 month, 3 months
|
|
Caregiver Stress Outcome
Time Frame: 1 month, 3 months
|
Compared to caregivers in the sleep education control group, caregivers in the CoMPoSER intervention will experience less perceived stress.
The Perceived Stress Scale (PSS) will be used to assess perceived stress among caregivers.
The PSS has 10 items.
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
1 month, 3 months
|
|
Caregiver Wellbeing Outcome (Burden)
Time Frame: 1 month, 3 months
|
Compared to caregivers in the sleep education control group, caregivers in the CoMPoSER intervention will experience improved wellbeing (less burden).
The Zarit Burden Scale will be used to assess caregiver wellbeing.
The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88.
Higher scores indicate greater burden/worse wellbeing.
|
1 month, 3 months
|
|
Caregiver Wellbeing Outcome (Depression)
Time Frame: 1 month, 3 months
|
Compared to caregivers in the sleep education control group, caregivers in the CoMPoSER intervention will experience improved wellbeing (less depression).
The Patient Health Questionnaire (PHQ-9) will be used to assess caregiver wellbeing (depression).
The PHQ-9 consists of 9 items rated on a 4-point Likert scale that ranges from 0 (not at all) to 4 (nearly every day) with the sum of scores ranging between 0-27.
Higher scores indicate greater depression/worse wellbeing.
|
1 month, 3 months
|
|
Stress Change
Time Frame: 1 month
|
Changes in diurnal salivary cortisol from baseline to 1 month will mediate the effect of CoMPoSER on insomnia symptoms in PLWD.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darina Petrovsky, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vitiello MV, Borson S. Sleep disturbances in patients with Alzheimer's disease: epidemiology, pathophysiology and treatment. CNS Drugs. 2001;15(10):777-96. doi: 10.2165/00023210-200115100-00004.
- Petrovsky DV, Ramesh P, McPhillips MV, Hodgson NA. Effects of music interventions on sleep in older adults: A systematic review. Geriatr Nurs. 2021 Jul-Aug;42(4):869-879. doi: 10.1016/j.gerinurse.2021.04.014. Epub 2021 Jun 2.
- Cheour S, Cheour C, Kilani C, Guemri A, Zineddine D, Khelifa R, Supriya R, Bragazzi NL, Cheour F, Baker JS, Gaied-Chortane S. Salivary Testosterone and Cortisol Levels in Tunisian Elderly Male Patients With Mild Alzheimer's Disease. Implications of Musical Therapy And/Or Physical Rehabilitation. Front Physiol. 2022 Aug 5;13:839099. doi: 10.3389/fphys.2022.839099. eCollection 2022.
- Takahashi T, Matsushita H. Long-term effects of music therapy on elderly with moderate/severe dementia. J Music Ther. 2006 Winter;43(4):317-33. doi: 10.1093/jmt/43.4.317.
- Gooneratne NS, Vitiello MV. Sleep in older adults: normative changes, sleep disorders, and treatment options. Clin Geriatr Med. 2014 Aug;30(3):591-627. doi: 10.1016/j.cger.2014.04.007. Epub 2014 Jun 12.
- Shum A, Taylor BJ, Thayala J, Chan MF. The effects of sedative music on sleep quality of older community-dwelling adults in Singapore. Complement Ther Med. 2014 Feb;22(1):49-56. doi: 10.1016/j.ctim.2013.11.003. Epub 2013 Nov 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
October 12, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
August 25, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00115115
- 1K23AG073618-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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