Speech DisordersNCT05369663
Personal Protective Equipment Effects
An observational study of Speech Disorders and Voice Disorders, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Disorders, Voice Disorders
- What is being tested?
- mask use
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2020to 16 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals. Based on health caregiving people (doctors, nurses)
Who may be able to join
- native Turkish speakers
Who cannot join
- having an acute respiratory system infection history of any vocal fold surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Personal Protective Equipment on Speech Acoustics
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.
- Conditions
- Speech Disorders, Voice Disorders
- Being tested
- mask use
- Keywords
- speech acoustics
- Medical subject headings
- Speech Disorders, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mask useDevice
face mask use
| Study group | Role | What they receive |
|---|---|---|
| no mask | no mask use | |
| surgical mask | surgical mask use Receives: Device: mask use | |
| N99 mask | N99 mask use Receives: Device: mask use | |
| face shield | face shield use Receives: Device: mask use | |
| surgical mask+ faceshield | surgical mask+ faceshield use Receives: Device: mask use | |
| N99 mask+ faceshield | N99 mask+ faceshield use Receives: Device: mask use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start16 Dec 2020
- Primary completion16 Jan 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet mutlu, Istanbul Medeniyet University
- Investigators
- ahmet mutlu, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369663
- Sponsor's protocol ID
- Effects on speech acoustics
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personal Protective Equipment on Speech Acoustics
- ClinicalTrials.gov ID
- NCT05369663
- Acronym / sponsor ID
- Effects on speech acoustics
- Conditions
- Speech Disorders, Voice Disorders
- Keywords
- speech acoustics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 16 Jan 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| no mask | – | –no mask use |
| surgical mask | – | Device: mask usesurgical mask use |
| N99 mask | – | Device: mask useN99 mask use |
| face shield | – | Device: mask useface shield use |
| surgical mask+ faceshield | – | Device: mask usesurgical mask+ faceshield use |
| N99 mask+ faceshield | – | Device: mask useN99 mask+ faceshield use |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals. Based on health caregiving people (doctors, nurses)
Key inclusion criteria (1 listed)
- native Turkish speakers
Key exclusion criteria (1 listed)
- having an acute respiratory system infection history of any vocal fold surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mask useface mask use | Device | N99 mask, N99 mask+ faceshield, face shield, surgical mask, surgical mask+ faceshield |
Primary outcome
The change on voice acoustics due to different personal protective equipments use
Time frame: 1 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 34550454Gama 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmet mutlu principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Disorders and Voice Disorders, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change on voice acoustics due to different personal protective equipments use (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.