Effect of Soundscape on People With Dementia.

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04809545
Collaborator
University Ghent (Other), University of Toronto (Other)
50
1
2
11.3
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Acusticare
  • Other: Treatment as usual
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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)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 (Investigator, Outcomes Assessor)
Masking Description:
Single-blind study where the intervention is delivered outside of the hours of the investigator and outcomes assessor.
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Personalized Soundscape Effects on Persons With Dementia; a Pilot Randomized Clinical Trial
Actual Study Start Date :
Apr 21, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Active Comparator: Treatment as Usual

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
Usual care provided on the Specialized Dementia Unit

Outcome Measures

Primary Outcome Measures

  1. Change over 6 weeks in Neuropsychiatric Inventory- total score [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

Secondary Outcome Measures

  1. Change over 6 weeks in the Pittsburgh Agitation Scale-- Resisting Care subscale [Baseline and weekly over 6 weeks]

    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

  2. Change over 6 weeks in the Pittsburgh Agitation Scale-- Total score [Baseline and weekly over 6 weeks]

    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

  3. Change over 6 weeks in Neuropsychiatric Inventory Agitation Subscale [Baseline and weekly over 6 weeks]

    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

  4. Change over 6 weeks in Neuropsychiatric Inventory Aggression subscale [Baseline and weekly over 6 weeks]

    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

  5. Change over 6 weeks in Neuropsychiatric Inventory Dysphoria subscale [Baseline and weekly over 6 weeks]

    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

  6. Change in Neuropsychiatric Inventory Anxiety subscale [Baseline and weekly over 6 weeks]

    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

  7. Change in Qualidem [Baseline, Week 6]

    Dementia-related quality of life

Other Outcome Measures

  1. Change in staff feedback on 5-point scale over 6 weeks [Baseline and daily over 6 weeks]

    Staff can provide real-time feedback on a daily basis on resident mood and behaviour using a 5-button scale

  2. Change in accelerometer-measured nocturnal activity level over time [Weeks 2,4,5 and 6]

    Using an accelerometer, will assess activity levels overnight as a measure of sleep fragmentation

  3. Change in heart rate variability over time [Weeks 2,4,5 and 6]

    Heart rate variability as a measure of stress

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Rehabilitation Institute, University Health Network Toronto Ontario Canada M5G2A2

Sponsors and Collaborators

  • University Health Network, Toronto
  • University Ghent
  • University of Toronto

Investigators

  • Principal Investigator: Andrea Iaboni, MD DPhil, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04809545
Other Study ID Numbers:
  • 20-5067
First Posted:
Mar 22, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021