Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Behavioural and Psychiatric Symptoms of Dementia
  • Dementia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Investigator, Outcomes Assessor)Masking Description: Single-blind study where the intervention is delivered outside of the hours of the investigator and outcomes assessor.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

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 w...

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).

Tracking Information

NCT #
NCT04809545
Collaborators
  • University Ghent
  • University of Toronto
Investigators
Principal Investigator: Andrea Iaboni, MD DPhil University Health Network, Toronto