Effect of Soundscape on People With Dementia.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

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

Conditions
-----------------
Dementia, Behavioural and Psychiatric Symptoms of Dementia

Intervention / Treatment
-----------------
* Other: Acusticare
* Other: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years or older Diagnosis of Dementia Symptoms of BPSD at baseline English speaking Assigned a private room with AcustiCare installed Exclusion Criteria: Severe hearing impairment Receiving end-of-life care

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind repeated-measures randomized controlled study with two parallel arms, Intervention and Treatment As Usual (TAU) with a 2:4:1 design (two baseline measures, four intervention measures, 1 post-intervention)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The study intervention consists of the delivery of a soundscape in the private rooms of the participant during the morning and evening. The soundscape is personalized and consists of a collection of natural sounds, birdsongs, kitchen sounds, music, bell sound, outdoor sounds, water/rain sounds, and similar. | Other: Acusticare<br>* Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.<br>|
| Active Comparator: Treatment as Usual<br>As part of usual care, patients on the Specialized Dementia Unit receive a comprehensive assessment of their health and symptoms of dementia involving consultation by a geriatric psychiatrist, geriatrician, physical therapist, occupational therapist, and recreation therapist, and pharmacological and non-pharmacological treatment plans are developed and executed. All participants in the study will receive this standard of care | Other: Treatment as usual<br>* Usual care provided on the Specialized Dementia Unit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over 6 weeks in Neuropsychiatric Inventory- total score | 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 | Baseline and weekly over 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale | Assessment of resistance to care on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score | Assessment of behavioural symptoms on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale | Assessment of agitation on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale | Assessment of aggression on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale | Assessment of dysphoria on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change in Neuropsychiatric Inventory Anxiety subscale | Assessment of anxiety on a weekly basis over the study duration will be included in a longitudinal mixed effects model as part of a repeated measures design | Baseline and weekly over 6 weeks | 
| Change in Qualidem | Dementia-related quality of life | Baseline, Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soundscape, Sonic environment, Neuropsychiatric symptoms, Dementia, Environmental design