Effect of Soundscape on People With Dementia.

NCT04809545 | Completed

• 1 other identifier: 20-5067
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Behavioural and Psychiatric Symptoms of Dementia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale

  Baseline and weekly over 6 weeks

• Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score

  Baseline and weekly over 6 weeks

• Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale

  Baseline and weekly over 6 weeks

• Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale

  Baseline and weekly over 6 weeks

• Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale

  Baseline and weekly over 6 weeks

Other Outcomes (3)

• Change in staff feedback on 5-point scale over 6 weeks

  Baseline and daily over 6 weeks

• Change in accelerometer-measured nocturnal activity level over time

  Weeks 2,4,5 and 6

• Change in heart rate variability over time

  Weeks 2,4,5 and 6

Study Arms (2)

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.

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

Other: Treatment as usual

Interventions

Acusticare OTHER

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

Intervention

Treatment as usual OTHER

Usual care provided on the Specialized Dementia Unit

Treatment as Usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• Diagnosis of Dementia
• Symptoms of BPSD at baseline
• English speaking
• Assigned a private room with AcustiCare installed

You may not qualify if:

• Severe hearing impairment
• Receiving end-of-life care

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University Ghent: collaborator
• University of Toronto: collaborator

Study Sites (1)

Toronto Rehabilitation Institute, University Health Network

Toronto, Ontario, M5G2A2, Canada

Location

Related Publications (3)

• 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.

  PMID: 31817300 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 39350940 DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Andrea Iaboni, MD DPhil

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind study where the intervention is delivered outside of the hours of the investigator and outcomes assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: April 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)