The Feasibility of a Tailored Music Intervention to Reduce Symptoms of Sleep Disruption in Older Adults With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Study Measures Completion
研究概览
简要总结
The specific aims of this studyare to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with dementia suffering from sleep disruption. Sixty dyads (older adults with dementia and their caregivers) will be randomized to receive the tailored music intervention immediately or following a four week delay.
详细描述
Sleep disruption in older adults living with Alzheimer's disease and related dementias (ADRD) is very debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Furthermore, sleep disruption is linked to poor health outcomes in caregivers (CGs), such as poor quality of life and increased CG burden. Given the potential harmful side effects of pharmacologic treatment, non-pharmacologic approaches, such as music, may provide a safer alternative to reducing sleep disruption in this vulnerable population. Listening to music has been shown to decrease agitation, anxiety and depression in nursing home residents with ADRD. A growing body of literature suggests that individualized music may improve sleep quality in older adults with early memory loss, but its efficacy has not been demonstrated in older adults with ADRD in the community, where most older adults with ADRD live. If proven feasible and acceptable, tailored music interventions can then be tested for efficacy in reducing sleep disruption.
Music selections will be individualized to older adults with ADRD and account for known sleep-inducing properties. Feasibility of processes that are key to the success of the subsequent study will be examined. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective (proxy reported) sleep quality measures. In addition, qualitative data will be solicited from the dyads examining the acceptability and satisfaction with the intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 and older
- •Physician diagnosis of probable ADRD using standard assessments and diagnostic criteria
- •Presence of sleep problems determined first during phone screening using NPI sleep disorders item, then using proxy-rated Sleep Disorders Inventory (SDI) (presence of at least one sleep disturbance symptom of moderate severity)
- •Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia or opioids in the past 90 days (typical time frame in clinical trials) prior to enrollment to minimize confounding effects of medications
- •Tolerates and agrees to wear wrist actigraph
- •Responsive to their environment (e.g., able to understand short commands)
- •Sufficient English to complete questionnaires
排除标准
- •Planned transition to another residential or institutional care setting in less than 3 months
- •Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet)
- •Presence of extrapyramidal symptoms affecting non-dominant hand which may include persons with the following diagnoses: schizophrenia, bipolar disorder, Huntington's disease, Parkinson's disease, Lewy Body dementia due to REM sleep disorders
- •Currently enrolled in an interventional clinical trial for ADRD aimed to improve sleep
- •Acute sleep disruption within 2 weeks of screening as it may indicate sleep disorders not related to ADRD or delirium
- •End stage disease (i.e. cancer, bed bound)
结局指标
主要结局
Study Measures Completion
时间窗: 4 weeks
Number of participants who complete study measures in accordance with protocol schedule of events
Acceptability of the study components
时间窗: 4 weeks
Two questions from a survey developed by Gitlin and colleagues (2010) which examines satisfaction with participation and perceived benefits. The survey uses a scale of 1-3 (1- Not at all to 3-A great deal) to rate caregiver perceived 1) overall benefit from participating in the study and 2) improvement in life of person's with dementia. Min score 2, maximum score 6 (with higher scores indicating greater satisfaction and perceived benefits)
次要结局
- The Quality of Life in Alzheimer's Disease Scale (QOL-AD)(Baseline and 4 weeks)
- Objective sleep measures(4 weeks)
研究者
Darina Petrovsky, PhD, RN
Postdoctoral Research Fellow
University of Pennsylvania