The Impact of Music Intervention on Sleep

NCT06088810 | Not Yet Recruiting DMC

• 2 other identifiers: PRO001151151K23AG073618-01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dementia

Keywords

Dementia

Outcome Measures

Primary Outcomes (1)

• Acceptability

  At least 80% of the dyads will find the intervention acceptable

  4 weeks

Secondary Outcomes (6)

• PLWD Objective Sleep Outcomes

  1 month, 3 months

• PLWD Subjective Sleep Outcomes

  1 month, 3 months

• Caregiver Stress Outcome

  1 month, 3 months

• Caregiver Wellbeing Outcome (Burden)

  1 month, 3 months

• Caregiver Wellbeing Outcome (Depression)

  1 month, 3 months

Study Arms (2)

Sleep Education Group

ACTIVE COMPARATOR

Participants in this group will receive sleep education.

Other: Sleep Education

CoMPoSER Intervention Group

EXPERIMENTAL

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

Other: CoMPoSER intervention group

Interventions

CoMPoSER intervention group OTHER

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

CoMPoSER Intervention Group

Sleep Education 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.

Sleep Education Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Related Publications (6)

• 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.

  PMID: 11602004 BACKGROUND

• 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.

  PMID: 34090233 BACKGROUND

• 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.

  PMID: 35991172 BACKGROUND

• 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.

  PMID: 17348758 BACKGROUND

• 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.

  PMID: 25037297 BACKGROUND

• 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.

  PMID: 24559816 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Darina Petrovsky

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darina Petrovsky

CONTACT

919-684-3786; darina.petrovsky@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share