The Impact of Music Intervention on Sleep

Not Applicable

Not yet recruiting

• Conditions: Dementia
• Interventions: Other: Sleep Education; Other: CoMPoSER intervention group

• Registration Number: NCT06088810
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Study Start: 2025-04-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Education Group	Sleep Education	Participants in this group will receive sleep education.
CoMPoSER Intervention Group	CoMPoSER intervention group	Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement.

Primary Outcome Measures

Name	Time	Method
Acceptability	4 weeks	At least 80% of the dyads will find the intervention acceptable

Secondary Outcome Measures

Name	Time	Method
PLWD Objective Sleep Outcomes	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.
Caregiver Wellbeing Outcome (Depression)	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.
Stress Change	1 month	Changes in diurnal salivary cortisol from baseline to 1 month will mediate the effect of CoMPoSER on insomnia symptoms in PLWD.
PLWD Subjective Sleep Outcomes	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.
Caregiver Wellbeing Outcome (Burden)	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.
Caregiver Stress Outcome	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.