The Impact of Music Intervention on Sleep

Duke University

Status: Not yet enrolling

Conditions: Dementia

Treatments: Other: CoMPoSER intervention group; Other: Sleep Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06088810

PRO00115115

1K23AG073618-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Sleep Education Group

Active Comparator group

Description:

Participants in this group will receive sleep education.

Treatment:

Other: Sleep Education

CoMPoSER Intervention Group

Experimental group

Description:

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

Treatment:

Other: CoMPoSER intervention group