Personal Protective Equipment Effects

Voice Disorders Clinical Trial

Official title:

Effects of Personal Protective Equipment on Speech Acoustics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369663
• Other study ID #: Effects on speech acoustics
• Status: Completed
• Start date: December 16, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: May 2022
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• native Turkish speakers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Disease
• Speech Disorders
• Voice Disorders

Intervention

Device:
• mask use
face mask use

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 [??] 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.	1 months