Effect of Soundscape on People With Dementia.

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809545
• Other study ID #: 20-5067
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioural and Psychiatric Symptoms of Dementia
• Dementia

Intervention

Other:
• Acusticare
Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.
• Treatment as usual
Usual care provided on the Specialized Dementia Unit

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute, University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	University Ghent, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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). pii: E4904. doi: 10.3390/ijerph16244904. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in heart rate variability over time	Heart rate variability as a measure of stress	Weeks 2,4,5 and 6
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Qualidem	Dementia-related quality of life	Baseline, Week 6