Clinical trial NCT04809545: Effect of Soundscape on People With Dementia.
Official title: Evaluation of Personalized Soundscape Effects on Persons With Dementia; a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Behavioural and Psychiatric Symptoms of Dementia
Keywords: Soundscape
Sonic environment
Neuropsychiatric symptoms
Dementia
Environmental design
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University Ghent
name: University of Toronto
First posted: 2021-03-22
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change over 6 weeks in Neuropsychiatric Inventory- total score
timeFrame: Baseline and weekly over 6 weeks
Secondary outcomes:
measure: Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale
timeFrame: Baseline and weekly over 6 weeks
measure: Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score
timeFrame: Baseline and weekly over 6 weeks
measure: Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale
timeFrame: Baseline and weekly over 6 weeks
measure: Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale
timeFrame: Baseline and weekly over 6 weeks
measure: Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale
timeFrame: Baseline and weekly over 6 weeks
measure: Change in Neuropsychiatric Inventory Anxiety subscale
timeFrame: Baseline and weekly over 6 weeks
measure: Change in Qualidem
timeFrame: Baseline, Week 6
Other outcomes:
measure: Change in staff feedback on 5-point scale over 6 weeks
timeFrame: Baseline and daily over 6 weeks
measure: Change in accelerometer-measured nocturnal activity level over time
timeFrame: Weeks 2,4,5 and 6
measure: Change in heart rate variability over time
timeFrame: Weeks 2,4,5 and 6
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andrea Iaboni, MD DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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