Effect of Soundscape on People With Dementia.

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Behavioural and Psychiatric Symptoms of Dementia
• Intervention / Treatment: Other: Acusticare; Other: Treatment as usual

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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2A2
      • Toronto Rehabilitation Institute, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 65 years or older
2. Diagnosis of Dementia
3. Symptoms of BPSD at baseline
4. English speaking
5. Assigned a private room with AcustiCare installed

Exclusion Criteria:

1. Severe hearing impairment
2. Receiving end-of-life care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.
Active Comparator: Treatment as Usual; 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; Usual care provided on the Specialized Dementia Unit

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in staff feedback on 5-point scale over 6 weeks	Staff can provide real-time feedback on a daily basis on resident mood and behaviour using a 5-button scale	Baseline and daily over 6 weeks
Change in accelerometer-measured nocturnal activity level over time	Using an accelerometer, will assess activity levels overnight as a measure of sleep fragmentation	Weeks 2,4,5 and 6
Change in heart rate variability over time	Heart rate variability as a measure of stress	Weeks 2,4,5 and 6

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: University of Toronto; University Ghent
• Investigators: Principal Investigator: Andrea Iaboni, MD DPhil, University Health Network, Toronto

Publications and helpful links

General Publications

• Devos P, Aletta F, Thomas P, Petrovic M, Vander Mynsbrugge T, Van de Velde D, De Vriendt P, Botteldooren D. Designing Supportive Soundscapes for Nursing Home Residents with Dementia. Int J Environ Res Public Health. 2019 Dec 4;16(24):4904. doi: 10.3390/ijerph16244904.
• Devos, P., Aletta, F., Vander Mynsbrugge, T., Thomas, P., Filipan, K., Petrovic, M., ... & Botteldooren, D. (2018, December). Soundscape design for management of behavioral disorders: a pilot study among nursing home residents with dementia. In INTER-NOISE and NOISE-CON Congress and Conference Proceedings (Vol. 258, No. 5, pp. 2104-2111). Institute of Noise Control Engineerin

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Dementia; Neuropsychiatric symptoms; Soundscape; Sonic environment; Environmental design
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 20-5067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No