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NCT Number: NCT06088810

The Impact of Music Intervention on Sleep

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University School of Nursing

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Darina Petrovsky

CONTACT

[email protected]

919-681-7041

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability

    Time frame: 4 weeks

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Darina Petrovsky

CONTACT

[email protected]

919-684-3786

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

The Impact of Music Intervention on Sleep: CoMPoSER Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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