The Impact of Music Intervention on Sleep

Dementia Clinical Trial

Official title:

The Impact of Music Intervention on Sleep: CoMPoSER Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088810
• Other study ID #: Pro2023000592
• Secondary ID: 1K23AG073618-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Darina Petrovsky
• Phone: 848-932-6898
• Email: darina.petrovsky[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Aging (NIA)

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	At least 80% of the dyads will find the intervention acceptable	4 weeks
Secondary	PLWD Objective Sleep Outcomes	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
Secondary	PLWD Subjective Sleep Outcomes	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
Secondary	Caregiver Stress Outcome	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
Secondary	Caregiver Wellbeing Outcome (Burden)	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
Secondary	Caregiver Wellbeing Outcome (Depression)	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
Secondary	Stress Change	Changes in diurnal salivary cortisol from baseline to 1 month will mediate the effect of CoMPoSER on insomnia symptoms in PLWD.	1 month