The Impact of Music Intervention on Sleep: CoMPoSER Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CoMPoSER Intervention Group
Participants in this group will use a mobile application that plays calming music personalized for sleep enhancement.
干预措施: CoMPoSER intervention group (Other)
Sleep Education Group
Participants in this group will receive sleep education.
干预措施: Sleep Education (Other)
结局指标
主要结局
Acceptability
时间窗: 4 weeks
At least 80% of the dyads will find the intervention acceptable
次要结局
- Caregiver Stress Outcome(1 month, 3 months)
- PLWD Objective Sleep Outcomes(1 month, 3 months)
- Caregiver Wellbeing Outcome (Depression)(1 month, 3 months)
- Stress Change(1 month)
- PLWD Subjective Sleep Outcomes(1 month, 3 months)
- Caregiver Wellbeing Outcome (Burden)(1 month, 3 months)