The Impact of Music Intervention on Sleep
Purpose
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.
Condition
- Dementia
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Sleep Education Group |
Participants in this group will receive sleep education. |
|
|
Experimental CoMPoSER Intervention Group |
Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement. |
|
Recruiting Locations
Durham, North Carolina 27710
More Details
- Status
- Recruiting
- Sponsor
- Duke University
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.