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OpenTrials
Completed

NCT Number: NCT04809545

Effect of Soundscape on People With Dementia.

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute, University Health Network

Toronto, Ontario, M5G2A2, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Acusticare

Other

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

Treatment as Usual

Other

Usual care provided on the Specialized Dementia Unit

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Week 6

    Dementia-related quality of life

Other outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Weeks 2,4,5 and 6

    Heart rate variability as a measure of stress

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • University Ghent
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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