Clinical trial NCT06088810: The Impact of Music Intervention on Sleep
Official title: The Impact of Music Intervention on Sleep: CoMPoSER Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Dementia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 4 weeks
Secondary outcomes:
measure: PLWD Objective Sleep Outcomes
timeFrame: 1 month, 3 months
measure: PLWD Subjective Sleep Outcomes
timeFrame: 1 month, 3 months
measure: Caregiver Stress Outcome
timeFrame: 1 month, 3 months
measure: Caregiver Wellbeing Outcome (Burden)
timeFrame: 1 month, 3 months
measure: Caregiver Wellbeing Outcome (Depression)
timeFrame: 1 month, 3 months
measure: Stress Change
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Darina Petrovsky
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.