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Effect of Soundscape on People With Dementia.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04809545
Enrollment
33
Registered
2021-03-22
Start date
2021-04-21
Completion date
2022-06-30
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioural and Psychiatric Symptoms of Dementia, Dementia

Keywords

Soundscape, Sonic environment, Neuropsychiatric symptoms, Dementia, Environmental design

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).

Interventions

OTHERAcusticare

Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.

OTHERTreatment as usual

Usual care provided on the Specialized Dementia Unit

Sponsors

University Ghent
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.

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)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change over 6 weeks in Neuropsychiatric Inventory- total scoreBaseline and weekly over 6 weeksAssessments 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

Secondary

MeasureTime frameDescription
Change over 6 weeks in Neuropsychiatric Inventory Agitation SubscaleBaseline and weekly over 6 weeksAssessment 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
Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscaleBaseline and weekly over 6 weeksAssessment 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
Change in Neuropsychiatric Inventory Anxiety subscaleBaseline and weekly over 6 weeksAssessment 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
Change in QualidemBaseline, Week 6Dementia-related quality of life
Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscaleBaseline and weekly over 6 weeksAssessment 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
Change over 6 weeks in the Pittsburgh Agitation Scale-- Total scoreBaseline and weekly over 6 weeksAssessment 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
Change over 6 weeks in Neuropsychiatric Inventory Aggression subscaleBaseline and weekly over 6 weeksAssessment 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

Other

MeasureTime frameDescription
Change in heart rate variability over timeWeeks 2,4,5 and 6Heart rate variability as a measure of stress
Change in staff feedback on 5-point scale over 6 weeksBaseline and daily over 6 weeksStaff can provide real-time feedback on a daily basis on resident mood and behaviour using a 5-button scale
Change in accelerometer-measured nocturnal activity level over timeWeeks 2,4,5 and 6Using an accelerometer, will assess activity levels overnight as a measure of sleep fragmentation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026