DementiaNCT04809545
Effect of Soundscape on People With Dementia.
A study testing Acusticare and Treatment as usual in people with Dementia and Behavioural and Psychiatric Symptoms of Dementia, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Behavioural and Psychiatric Symptoms of Dementia
- What is being tested?
- Acusticare and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older
- Diagnosis of Dementia
- Symptoms of BPSD at baseline
- English speaking
- Assigned a private room with AcustiCare installed
Who cannot join
- Severe hearing impairment
- Receiving end-of-life care
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute, University Health Network
Toronto, Ontario, M5G2A2
About this study
Official title: 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.
Read the 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).
- Being tested
- Acusticare, Treatment as usual
- Keywords
- Soundscape, Sonic environment, Neuropsychiatric symptoms, Dementia, Environmental design
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcusticareOther
Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.
Treatment as usualOther
Usual care provided on the Specialized Dementia Unit
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Acusticare |
| Treatment as Usual | Active comparator | 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 Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and weekly over 6 weeks
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and weekly over 6 weeks
Change in Qualidem
Dementia-related quality of life
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start21 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Andrea Iaboni, MD DPhil, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809545
- Sponsor's protocol ID
- 20-5067
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31817300Devos, 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
Talebzadeh A, Botteldooren D, Thomas P, Stewart S, Van de Velde D, De Vriendt P, Devos P, Iaboni A. Effect of Soundscape Augmentation on Behavioral Symptoms in People With Dementia: A Pilot Randomized Controlled Trial. Innov Aging. 2024 Aug 5;8(9):igae069. doi: 10.1093/geroni/igae069. eCollection 2024.
PubMed 39350940
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Personalized Soundscape Effects on Persons With Dementia; a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04809545
- Acronym / sponsor ID
- 20-5067
- Keywords
- Soundscape, Sonic environment, Neuropsychiatric symptoms, Dementia, Environmental design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University Ghent, University of Toronto
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AcusticareThe 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. |
| Treatment as Usual | Active comparator | Other: Treatment as usualAs 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years or older
- Diagnosis of Dementia
- Symptoms of BPSD at baseline
- English speaking
- Assigned a private room with AcustiCare installed
Key exclusion criteria (2 listed)
- Severe hearing impairment
- Receiving end-of-life care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcusticareAcusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room. | Other | Intervention |
| Treatment as usualUsual care provided on the Specialized Dementia Unit | Other | Treatment as Usual |
Primary outcome
Change over 6 weeks in Neuropsychiatric Inventory- total score
Time frame: Baseline and weekly over 6 weeks
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
7 secondary outcomes
Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale
Time frame: Baseline and weekly over 6 weeks
Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score
Time frame: Baseline and weekly over 6 weeks
Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale
Time frame: Baseline and weekly over 6 weeks
Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale
Time frame: Baseline and weekly over 6 weeks
Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale
Time frame: Baseline and weekly over 6 weeks
Change in Neuropsychiatric Inventory Anxiety subscale
Time frame: Baseline and weekly over 6 weeks
Change in Qualidem
Time frame: Baseline, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 31817300Devos 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.
- BackgroundDevos, 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
- Derived from this study: PubMed 39350940Talebzadeh A, Botteldooren D, Thomas P, Stewart S, Van de Velde D, De Vriendt P, Devos P, Iaboni A. Effect of Soundscape Augmentation on Behavioral Symptoms in People With Dementia: A Pilot Randomized Controlled Trial. Innov Aging. 2024 Aug 5;8(9):igae069. doi: 10.1093/geroni/igae069. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Iaboni, MD DPhil principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acusticare and Treatment as usual in people with Dementia and Behavioural and Psychiatric Symptoms of Dementia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over 6 weeks in Neuropsychiatric Inventory- total score (time frame: Baseline and weekly over 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809545, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.