Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000393853
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
8/04/2021
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of wearing a face mask on brain functioning in adults
Scientific title
The effects of wearing a face mask on haemoglobin concentration and brain activity in healthy adults.
Secondary ID [1] 303401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to the effect of wearing face masks on cognitive functioning in young adults.

Trial Id: ACTRN12620001215910

Health condition
Health condition(s) or problem(s) studied:
Brain function 320689 0
Condition category
Condition code
Neurological 318533 318533 0 0
Studies of the normal brain and nervous system
Mental Health 318534 318534 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 318848 318848 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will come into the laboratory in the Department of Psychology for two visits (each ~60 min) separated by 1 week. Participants will be asked to wear a PPE mask (Safe Plus anti-fog, earloop type, manufactured by BH medical products Co., Ltd.) for one of the visits. Participants will wear the mask for at least 8 hours before commencing the experimental portion, which will last ~60 mins for a total 9 hours of mask wearing.
The experimental session involves the following sequence of events:
1. Complete the Mini Mental State Exam, Center for Epidemiological Studies - Depression scale (CES-D) and the Pittsburgh Sleep Quality Index (PSQI). Participants will not be informed of their scores.
2. Completion of simple computer-based cognitive tests (described below). Haemoglobin concentrations and electrical activity will be recorded over the frontal lobe throughout the performance of the cognitive tests (described below).

Cognitive Testing
Participants will perform a battery of different computer-based cognitive tests. Throughout the performance of the cognitive tests, hemoglobin concentrations and electrical activity will be recorded concurrently. The cognitive tests involve viewing a display on a computer monitor and then pressing a button. The responses involve indicating the location or identifying of a target stimulus. Each response and response latency will be recorded. Button presses will be made on a two-button response box. No visual or audio recordings are involved, and all recordings are completely non-invasive. The experiments are not difficult or stressful and participants will be encouraged to rest as often as they please.

Hemoglobin concentrations and electrical activity measures
Concentrations of oxygenated and deoxygenated hemoglobin will be measured continuously using near-infrared spectroscopy (NIRS). This method assesses cerebral oxygenation changes. The NIRS technique is based on the relative transparency of human tissue to near-infrared light and on the oxygenation-dependent light absorption changes caused by the chromophores oxyhemoglobin [O2Hb] and deoxyhemoglobin [HHb]. It is completely non-invasive and painless.
Concurrently with NIRS, the electrical activity of the brain will be recorded using EEG. EEG refers to recordings from multiple electrodes placed over the scalp, to record underlying electrical activity from the brain over a period of time (commonly referred to as brain waves). The EEG technique measures ionic current-voltage fluctuations which result from within the neurons of the brain. EEG is completely non-invasive and painless.
This project was supervised by members of the research team.
Intervention code [1] 319706 0
Treatment: Devices
Comparator / control treatment
All aspects of the control session are identical to the mask wearing session, except that participants are not required to wear the mask during the day of participation and during cognitive testing.
Control group
Active

Outcomes
Primary outcome [1] 326488 0
Concentrations of oxygenated [O2Hb] haemoglobin as measured continuously using near-infrared spectroscopy (NIRS).

Bierre KL, Lucas SJ, Guiney H, Cotter JD, Machado L. (2017). Cognitive Difficulty Intensifies Age-related Changes in Anterior Frontal Hemodynamics: Novel Evidence from Near-infrared Spectroscopy. Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences, 72(2), 181-188.
Timepoint [1] 326488 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Primary outcome [2] 326801 0
Concentrations of deoxygenated haemoglobin [HHb] as measured continuously using near-infrared spectroscopy (NIRS).


Bierre KL, Lucas SJ, Guiney H, Cotter JD, Machado L. (2017). Cognitive Difficulty Intensifies Age-related Changes in Anterior Frontal Hemodynamics: Novel Evidence from Near-infrared Spectroscopy. Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences, 72(2), 181-188.
Timepoint [2] 326801 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Primary outcome [3] 326802 0
Sum of concentrations of oxygenated and deoxygenated haemoglobin [total-Hb] as measured continuously using near-infrared spectroscopy (NIRS).

Bierre KL, Lucas SJ, Guiney H, Cotter JD, Machado L. (2017). Cognitive Difficulty Intensifies Age-related Changes in Anterior Frontal Hemodynamics: Novel Evidence from Near-infrared Spectroscopy. Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences, 72(2), 181-188.
Timepoint [3] 326802 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Secondary outcome [1] 391673 0
the electrical activity of the brain (frontal lobe) as recorded using EEG.
Timepoint [1] 391673 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Secondary outcome [2] 391676 0
Basic visuomotor performance as assessed by reaction times (ms) on Pro task.
it was designed for this study.
References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.
White, N., Flannery, L., McClintock, A., & Machado, L. (2019).

Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [2] 391676 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Secondary outcome [3] 391678 0
Switching ability as assessed by reaction times (ms) on Pro/Anti task.
It was designed for this study.
References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.

White, N., Flannery, L., McClintock, A., & Machado, L. (2019).
Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [3] 391678 0
Assessed at two time points (i.e., mask wearing, and control) each one week apart.
Secondary outcome [4] 391679 0
Mood state (energetic) as assessed using the Visual Analogue Mood Scales (VAMS).
The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [4] 391679 0
Assessed at two time points (i.e., mask wearing, and control ), each one week apart.
Secondary outcome [5] 391680 0
Mood state (sad) as assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [5] 391680 0
Assessed at two time points (i.e., mask wearing, and control) each one week apart
Secondary outcome [6] 391681 0
Mood state (tense) as assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [6] 391681 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [7] 391682 0
Mood state (happy) as assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [7] 391682 0
Assessed at two time points (i..e, mask wearing, and control), each one week apart.
Secondary outcome [8] 391683 0
Mood state (tired) as assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [8] 391683 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [9] 391684 0
Mood state (calm) as assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [9] 391684 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [10] 392740 0
Inhibitory control as assessed by reaction times (ms) on Anti task.
it was designed for this study.
References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.

White, N., Flannery, L., McClintock, A., & Machado, L. (2019).
Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [10] 392740 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [11] 392741 0
selective attention as assessed by reaction times (ms) on Flanker task.

References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.
White, N., Flannery, L., McClintock, A., & Machado, L. (2019).

Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [11] 392741 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [12] 392742 0
Selective attention as assessed by reaction times (ms) on Simon task.

References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.

White, N., Flannery, L., McClintock, A., & Machado, L. (2019).
Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [12] 392742 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [13] 392743 0
Short term memory as assessed by total scores (i.e., the product of the maximum span and the total number of sequences recall correctly) on Forward Spatial memory.

References:

Kessels, R. P., van Zandvoort, M. J., Postma, A., Kappelle, L. J., & de Haan, E. H. (2000). The Corsi block-tapping task: standardization and normative data. Applied Neuropsychology, 7(4), 252–258. https://doi.org/10.1207/S15324826AN0704_8.
Timepoint [13] 392743 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [14] 392744 0
Working memory as assessed by total scores (i.e., the product of the maximum span and the total number of sequences recall correctly) on Backward Spatial memory.

References:

Kessels, R. P., van Zandvoort, M. J., Postma, A., Kappelle, L. J., & de Haan, E. H. (2000). The Corsi block-tapping task: standardization and normative data. Applied Neuropsychology, 7(4), 252–258. https://doi.org/10.1207/S15324826AN0704_8.
Timepoint [14] 392744 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [15] 392745 0
Working memory as assessed by overall accuracy on 2-back task.
References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),539–549. https://doi.org/10.1037/pas0000503.

White, N., Flannery, L., McClintock, A., & Machado, L. (2019).
Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [15] 392745 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.

Eligibility
Key inclusion criteria
- At least 18 years of age.
- Normal or corrected-to-normal vision.
- Comfortable wearing a face mask for at least 8 hours.
- No scalp conditions and comfortable with us placing equipment on your head.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Chronic Obstructive Pulmonary Disease (COPD) based on self report.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
We will use paired sample t tests to determine whether wearing face masks affect brain functioning. Dropouts will be replaced to ensure a fully counterbalanced design with session order. If any missing data is deemed not missing at random, care will be taken to characterize it relative to other data.
The sensitivity power analysis using G*Power (Faul, 2007) indicated that with a sample size of 50 participants, alpha level of 0.05, and a desired power of 80% power, we will be able to detect a small to medium effect of wearing a face mask on brain functioning (Cohen's d = 0.4).
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G* Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. doi:10.3758/BF03193146

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/02/2021
Date of last participant enrolment
Anticipated
31/05/2021
Actual
Date of last data collection
Anticipated
7/06/2021
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 23445 0
New Zealand
State/province [1] 23445 0
OTAGO

Funding & Sponsors
Funding source category [1] 307817 0
University
Name [1] 307817 0
University of Otago
Country [1] 307817 0
New Zealand
Primary sponsor type
Individual
Name
Liana Machado
Address
Department of Psychology
University of Otago
362 Leith Street,
Dunedin 9016.
PO Box 56,
Dunedin 9054,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 308523 0
Individual
Name [1] 308523 0
Neda Nasrollahi
Address [1] 308523 0
Department of Psychology
University of Otago
362 Leith Street,
Dunedin 9016.
PO Box 56,
Dunedin 9054,
New Zealand
Country [1] 308523 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307823 0
University of Otago Human Ethics Committee
Ethics committee address [1] 307823 0
University Of Otago
Academic Committees Office
1st Floor, Scott/Shand House
90 St David's Street, North Dunedin
Dunedin 9016
Ethics committee country [1] 307823 0
New Zealand
Date submitted for ethics approval [1] 307823 0
Approval date [1] 307823 0
28/10/2020
Ethics approval number [1] 307823 0
20/088

Summary
Brief summary
The current research aims to provide a more complete characterization of the effects of wearing face masks (PPE masks) on hemodynamic/EEG responses (measured over the frontal lobe) to cognitive task engagement in adults. The research proposed here will investigate if wearing a PPE mask affects cognitive performance and brain patterns in adults. Based on CDC recommendations, wearing facemasks is a critical tool to prevent COVID-19 spread. Showing that wearing a facemask has no adverse effects has the potential to help allay public concern and increase adherence. Alternatively, identifying any adverse effects would provide important information that could help individuals make informed decisions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108626 0
A/Prof Liana Machado
Address 108626 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 108626 0
New Zealand
Phone 108626 0
+64 3 479 7622
Fax 108626 0
Email 108626 0
liana@psy.otago.ac.nz
Contact person for public queries
Name 108627 0
Ms Neda Nasrollahi
Address 108627 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 108627 0
New Zealand
Phone 108627 0
+64 3 479 4077
Fax 108627 0
Email 108627 0
nasne646@student.otago.ac.nz
Contact person for scientific queries
Name 108628 0
Ms Neda Nasrollahi
Address 108628 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 108628 0
New Zealand
Phone 108628 0
+64 3 479 4077
Fax 108628 0
Email 108628 0
nasne646@student.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Data will be made available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be available from the principal investigator upon request.
liana@psy.otago.ac.nz

nasne646@student.otago.ac.nz


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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