跳至主要内容
临床试验/NCT04809545
NCT04809545已完成不适用

Evaluation of Personalized Soundscape Effects on Persons With Dementia; a Pilot Randomized Clinical Trial

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Change over 6 weeks in Neuropsychiatric Inventory- total score

研究概览

简要总结

In the last few decades, insights into the impact of the sonic environment on persons have grown to include not only the adverse effects of extensive mechanical noise but also the beneficial effects of a well-designed sonic environment. People with dementia, however, perceive and understand the sonic environment differently. The most obvious difference is that the meanings they may give to the sounds they notice due to changing mental associations. However, also at an earlier perceptual stage, attention focusing and gating may be affected, reducing their ability to analyze a complex auditory scene. Behaviour associated with the appraisal of the sound environment may change with the emergence of dementia.

The objective of this study is to determine the effect size of a carefully tuned personalized sonic environment (delivered via AcustiCare) on agitation and distress (NPI and PAS), night sleep and stress (Via wristband) and on quality of life (QUALIDEM) in a population of older adults with dementia and behavioural symptoms.

详细描述

Research has shown the positive effect of natural and non-natural soundscape on people with severe or profound intellectual disabilities (Andringa & van den Bosch, 2013). Sound plays a role in generating a feeling of safety, in influencing the mood, and triggering a specific action. Bringing sound with this purpose, as targeted to the current activity can improve the behaviour. There is substantial research on the effect of noise (unwanted sound) on people's health and well-being. The health outcomes vary, but include cardiovascular disease, sleep disturbance, and annoyance.

In a previous study in people with dementia by the Belgian investigators in this study (Devos et al., 2019), they observed positive staff outcome measures, reflecting the value of the soundscape in improving their ability to provide care to people with dementia. They did not directly assess the benefits to residents in that study. There were no harms documented in the study, and if residents reacted not well to specific sound, the sound was removed from the soundscape.

The aim of this study is to build upon the previous research and evaluate the effect of a personalized soundscape on the well-being and behaviour of persons with dementia. In the soundscapes, we use only recognizable sounds, sounds that give persons with dementia a feeling of 'safety' or sounds that focus on the orientation (in time, place). We try to add a recognizable (safe, orientating) sound through the soundscape system. This soundscape supports the environment and makes the environment feel safer and more 'clear' for residents with dementia. In the previous research through co-design process with staff and family member the sounds were chosen (Devos et al, 2018).

Most of the existing studies in the field of the acoustic environment in health care are descriptive, and there is a need for a more rigorous evaluation of interventions. By using a pilot Randomized Control Trial (RCT) design, we will be able to establish the effect size of soundscape on outcomes of interest in this population of people with dementia. These results will support evidence-based practices by healthcare providers, architects, engineers and designers in implementing environmental health factors and designing better care facilities for people with dementia in the future.

The objective of this study is thus to determine the effect size of a carefully tuned personalized sonic environment (delivered via AcustiCare) on agitation and distress (NPI and PAS), night sleep and stress (Via wristband) and on quality of life (QUALIDEM).

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)

盲法说明

Single-blind study where the intervention is delivered outside of the hours of the investigator and outcomes assessor.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years or older
  • Diagnosis of Dementia
  • Symptoms of BPSD at baseline
  • English speaking
  • Assigned a private room with AcustiCare installed

排除标准

  • Severe hearing impairment
  • Receiving end-of-life care

结局指标

主要结局

Change over 6 weeks in Neuropsychiatric Inventory- total score

时间窗: Baseline and weekly over 6 weeks

Assessments of behavioural and psychological symptoms of dementia on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design

次要结局

  • Change in Neuropsychiatric Inventory Anxiety subscale(Baseline and weekly over 6 weeks)
  • Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score(Baseline and weekly over 6 weeks)
  • Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale(Baseline and weekly over 6 weeks)
  • Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale(Baseline and weekly over 6 weeks)
  • Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale(Baseline and weekly over 6 weeks)
  • Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale(Baseline and weekly over 6 weeks)
  • Change in Qualidem(Baseline, Week 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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