ClinicalTrials.gg
CompletedNCT05369663Updated May 16, 2022

Personal Protective Equipment Effects

An observational study in Speech Disorders and Voice Disorders, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Istanbul Medeniyet University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral, nasal, and conjunctival mucosas are related to contamination, and wearing personal protective equipment (PPE) is strongly suggested. Several communication problems between the patient and healthcare workers related to PPE use are reported. In this study, investigators aimed to investigate changes in the acoustic parameters of speech sounds when different PPE are used.

Read the detailed description

It was planned as a cross-sectional study enrolled 18 healthy male and female participants. After the informed consent, participants were asked to pronounce a [ɑː] vowel for at least 3 seconds for voice quality estimation. Afterward, all Turkish vowels were produced for a minimum of 200 ms. Finally, three Turkish fricative consonants ([f], [s], [ʃ]) were produced in consonant/vowel/consonant format and in different vowel contexts within a carrier sentence. Recordings were repeated for the following conditions: no PPE, surgical-mask, N99-mask, face shield, surgical-mask+faceshield, and N99+faceshield. All recordings were analyzed with proper statistical methods.

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Conditions studied

  • Speech Disorders
  • Voice Disorders

Keywords

  • speech acoustics
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In context

Speech Disorders

77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 23 observational studies indexed under Speech Disorders.

Browse Speech Disorders studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy individuals. Based on health caregiving people (doctors, nurses)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • native Turkish speakers

Exclusion criteria

Exclusion Criteria:

  • having an acute respiratory system infection history of any vocal fold surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • no mask

    no mask use

  • surgical mask

    surgical mask use

    Device: mask use

  • N99 mask

    N99 mask use

    Device: mask use

  • face shield

    face shield use

    Device: mask use

  • surgical mask+ faceshield

    surgical mask+ faceshield use

    Device: mask use

  • N99 mask+ faceshield

    N99 mask+ faceshield use

    Device: mask use

Interventions

  • Devicemask use

    face mask use

06

What researchers measure

Primary outcomes

  1. The change on voice acoustics due to different personal protective equipments use

    speech material for six different conditions: no PPE,surgical mask,N99 mask,face shield,surgical mask+ face shield, N99+face shield were recorded with a microphone.Recordings were performed in a random order. Obtained speech records were segmented according to the speech material and saved. Each of the segmented files was analyzed using Praat software and related scripts. The voice quality parameters were estimated on sustained \[ɑː\] vowels via Praat software (Praat is an open source software which enables voice acoustics analysis). Mean values of the different formant frequencies and formant bandwidth frequency values at midpoints of the analyzed segments of the vowels were measured. Spectral moments of the consonants were measured. The formant and spectral moment were measured using Praat scripts. All outcome measurements are in Hertz (Hz), so all measurements are held in primary outcome 1 measure section.

    Time frame: 1 months

07

Study locations

1 site
  • Istanbul Medeniyet University
    Istanbul, 34722, Turkey
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References and documents

Publications

  • Gama R, Castro ME, van Lith-Bijl JT, Desuter G. Does the wearing of masks change voice and speech parameters? Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1701-1708. doi: 10.1007/s00405-021-07086-9. Epub 2021 Sep 22. PubMed 34550454 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Jan 2021, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2022
First posted
May 11, 2022
StartActual
Dec 16, 2020
Primary completionActual
Jan 16, 2021
CompletionActual
Feb 16, 2021
Last update
May 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05369663
Responsible party
ahmet mutlu (asistant professor, Istanbul Medeniyet University) — Principal investigator
First posted
May 11, 2022
Start date
Dec 16, 2020
Primary completion
Jan 16, 2021
Completion
Feb 16, 2021
Last update
May 16, 2022

Study contacts

ahmet mutlu
principal investigator · Istanbul Medeniyet University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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