NCT05369663

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

April 25, 2022

Last Update Submit

May 10, 2022

Conditions

Keywords

speech acoustics

Outcome Measures

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.

    1 months

Study Arms (6)

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

mask useDEVICE

face mask use

N99 maskN99 mask+ faceshieldface shieldsurgical masksurgical mask+ faceshield

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • native Turkish speakers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34722, Turkey (Türkiye)

Location

Related 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.

    PMID: 34550454BACKGROUND

MeSH Terms

Conditions

Speech DisordersVoice Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • ahmet mutlu

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asistant professor

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 11, 2022

Study Start

December 16, 2020

Primary Completion

January 16, 2021

Study Completion

February 16, 2021

Last Updated

May 16, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations