The Impact of Music Intervention on Sleep

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Music Intervention on Sleep: CoMPoSER Trial

Conditions
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Dementia

Intervention / Treatment
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* Other: CoMPoSER intervention group
* Other: Sleep Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Education Group<br>Participants in this group will receive sleep education. | Other: Sleep Education<br>* Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.<br>|
| Experimental: CoMPoSER Intervention Group<br>Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement. | Other: CoMPoSER intervention group<br>* Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | At least 80% of the dyads will find the intervention acceptable | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia