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Trial registered on ANZCTR

Registration number

ACTRN12624001227583

Ethics application status

Approved

Date submitted

9/09/2024

Date registered

9/10/2024

Date last updated

9/10/2024

Date data sharing statement initially provided

9/10/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

How does built environment scale affect cognitive performance and neurophysiological measures in healthy adults?

Scientific title

A counter-balanced within-subjects study examining built environment scale on cognitive performance and neurophysiological measures in healthy adults

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1306-9257

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cognitive abilities (optimising working memory and facial emotion recognition performance)

Condition category

Condition code

Public Health

Other public health

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will assess how exposure to different physical room sizes affect cognitive performance and neurophysiological measures across an adult population. The aim is to better understand how the dimensions of interior rooms affect participants by constructing physical spaces, to replicate previously computer-modelled rooms which participants had been exposed to through a virtual reality study. Please note the 'rooms' constructed will not be fully enclosed (no back wall, enabling direct observation of the participant) and no ceiling (for safety). This physical configuration will match the Cave Automatic Virtual Environment setup of the previous study.

Our 'intervention' or 'condition' in this study is an 'enlarged' room with two side walls (4.5m length by 3.6m height) and a participant front-facing wall 3.6m length by 3.6m height). The walls will be constructed using structural pine, and finished with medium density fiberboard (MDF), painted white. The room consists of the three walls, a door-frame positioned in the center of the participant facing wall (height cue), and a wooden chair positioned in the right-hand corner of the room. A desk and chair will be positioned in the center of the constructed space for participants to complete cognitive tasks.

Each participant will be exposed to both the control and enlarged room (order randomized), where they will complete a social orientated task (facial emotion recognition) and executive functioning (working memory) task. They will be in each room for approximately 30-minutes, with a 5-minute wash-out period between where they will be invited to stand up, and take a short assisted walk with the researcher to the second room before being re-seated. Adherence during the computerised tasks will be monitored through the supervising researcher who will be observing the participant (standing outside of the room facing the participants back).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Our ‘control’ will be a room with two side walls (3m length by 2.4m height) and a participant front-facing wall (2.4m length by 2.4m height). The room consists of the three walls, a door-frame positioned in the center of the participant facing wall (height cue), and a wooden chair positioned in the right-hand corner of the room. A desk and chair will be positioned in the center of the constructed space for participants to complete cognitive tasks.

Control group

Active

Outcomes

Primary outcome [1]

Change in reaction time (behavioural indicator of performance).

Timepoint [1]

The reaction times will be captured over a set of trials that take place during exposure to each of the two rooms (control and condition/intervention).

Primary outcome [2]

Change in accuracy (% of correct to incorrect responses) as a measure of behavioral performance.

Timepoint [2]

A % rate will be created to understand how many trials were correct out of the total number of trials presented during exposure to each of the two rooms (control and condition/intervention).

Secondary outcome [1]

Change in neurophysiological activity (brain activity recorded through electroencephalography or 'EEG').

Timepoint [1]

We will collect a continuous recording which will be time stamped to indicate the room (control or condition) and the task (probe, retention, stimuli).

Secondary outcome [2]

Change in autonomic activity (heart rate variability or 'HRV').

Timepoint [2]

We will collect a continuous recording which will be marked with the room (control or condition).

Secondary outcome [3]

Change in autonomic activity (skin conductance response of 'SCR').

Timepoint [3]

We will collect a continuous recording which will be marked with the room (control or condition).

Eligibility

Key inclusion criteria

- Aged between 18 to 40 years
- Normal or corrected to normal vision.
- Able to read and understand English proficiently.

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Based on self-report, no prior diagnosis and/or undergoing treatment for, a psychiatric (other than depression or anxiety), neurological or neurodevelopmental condition, particularly excluding those undertaking pharmacological treatment.
- No prior training in built environment design as this has been shown to effect results.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Group size has been selected through an analysis of variance (ANOVA) repeated measures, within measures for planning data collection design and power. We have used a small to moderate effect size (f-value) of 0.25 with 1 group and 2 measures, with a correlation amongst repeated measures of 0.5 and non-sphericity correction of 1. This results in a sample size of n = 54 with an actual power of 0.95.

To analyse results, a linear mixed model will be used to enable the inclusion of participants who may have missing data and enable the participant to be entered as a random effect. Specifically, we will be looking at the difference in participants results between the room conditions (control to enlarged). We will also examine undertake exploratory analyses to understand participant socio-demographic, personality, and mood disorder factors on their results between the room conditions.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2024

Actual

Date of last participant enrolment

Anticipated

28/02/2025

Actual

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5072 - Magill

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

5095 - Mawson Lakes

Funding & Sponsors

Funding source category [1]

University

Name [1]

UniSA Justice & Society, University of South Australia

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/04/2024

Approval date [1]

12/09/2024

Ethics approval number [1]

206104

Summary

Brief summary

We spend an increasing amount of time within buildings yet have limited understanding of how the design of interior built environments affect our brain functioning and behaviour. Studies in a controlled laboratory setting using virtual reality have recently shown that enlarged room scale affects brain activity which has been associated with concentration and performance. Although promising that we may be able to optimise cognitive functioning through building design, it is important we understand if the computer-generated modelling and virtual reality presentation of a room elicits the same effect as physically constructed and experienced rooms. In this study, adults (aged 18-40, N=55) will be exposed to two rooms, where they will complete computerised cognitive tasks while neurophysiological measures are recorded. Mixed model analyses will be used to compare the measures between the two rooms. Overall, it is intended this study will help us understand if we can optimise the spaces we inhabit to support our cognitive performance.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Isabella Bower

Address

UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072

Country

Australia

Phone

+61 08 8302 7445

Fax

isabella.bower@unisa.edu.au

Contact person for public queries

Name

Isabella Bower

Address

UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072

Country

Australia

Phone

+61 08 8302 7445

Fax

isabella.bower@unisa.edu.au

Contact person for scientific queries

Name

Isabella Bower

Address

UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072

Country

Australia

Phone

+61 08 8302 7445

Fax

isabella.bower@unisa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual de-identified participant data underlying published results only.

When will data be available (start and end dates)?

From publication of the study findings (anticipated late 2025 to early 2026) with no end date imposed.

Available to whom?

Anyone who wishes to access it.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Data will be made available on Open Science Framework (www.osf.io). The Principle Investigator can also be contacted (isabella.bower@unisa.edu.au).

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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