Hearing DisordersNCT05728203
Audiologic Assessment of Call Center Operators
An observational study of Hearing Disorders, run by Assiut University.
Trial summary
1. Early detection of hearing affection in call center operators 2. Study the effect of this type of noise on the auditory brainstem response. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Disorders
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Nov 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Active working workers in call centers with minimum exposure 2year. * Had no previous auditory problems. * Their ages between [18-50] years old working at call centers from 6-12hours/day,5-6days a week.
Who may be able to join
- Active working workers in call centers with minimum exposure 2year.
- Had no previous auditory problems.
- Their ages between [18-50] years old working at call centers from 6-12hours/day,5-6days a week.
Who cannot join
- evidence of systemic illness [ cardiovascular, renal and diabetes]
- previous history of hearing loss and tinnitus before working at the call center.
- History of noise, ototoxic drugs and chemotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
- Early detection of hearing affection in call center operators
- Study the effect of this type of noise on the auditory brainstem response.
Read the detailed description
Occupational noise-induced hearing loss (ONIHL) is a common occupational disease as it is estimated that 1.3 billion people were suffering of hearing loss due to noise exposure. Worldwide, occupational noise exposure is responsible for 16% of cases of disabling hearing loss in adults Commonly, hearing loss interferes with communication and can hinder personal attention and cognition. Older people with mild hearing loss have a twofold increased risk of dementia, whereas those with severe hearing loss have a fivefold increased risk of dementia.
In the last years there was increase in the number of new forms of workplaces, such as call centers. In accordance with the British Health and Safety Executive, a call center is defined as a work environment where all basic employee's tasks are completed simultaneously by phone and on PC. The very first call centers appeared in Europe in Sweden, in the mid-70's of the last century. The last decade brought rapid development of call centers proven by 10percent growth in employment in this sector between 2002and 2007.
Sources of noise occurring in offices can be divided into four categories:
- human activity (for example: noise created by walking people, phone calls including speaker systems),
- office equipment (for example: computers, printers, copy machines, faxes , ringing phones , net devices, mobile headsets),
- building indoor installations (for example: ventilation , heating system and air condition system-HVAC.hydraulic and lift systems),
- outdoor noise (most often a result of traffic).
There are many factors that have impact on indoor noise level such as outside area noise ,neighbor workers from the side as well as from the upper and lower levels activity and finally ,the call center technical equipment, The loudest systems with regard to the last one are ventilation and air condition, in accordance to research , the level of background noise is not high (54-60db) and should not be considered to be a threat towards health ;however, due to focusing employee's involuntary attention on information delivered by noise ,it should be seen as an annoying factor.
To minimize negative auditory health effects on workers in call centers, it is important to assess, and diagnose early occupational hearing loss (OHL) and tinnitus among them. As, early reporting, diagnosis, and intervention can limit the severity of, OHL as it is mostly irreversible. To our knowledge no local previous studies were done in this area.
- Conditions
- Hearing Disorders
- Medical subject headings
- Hearing Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiologic assessment of call center operators
By using of audiometer to assess hearing loss and using of auditory brainstem response to assess effect of this type of noise on hearing
Measured: through study completion, an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
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 Hearing DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya yasser abdelrahman, Assiut University
- Investigators
- Eman A Sayed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728203
- Sponsor's protocol ID
- Audiologic Assessment
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pawlaczyk-Luszczynska M, Dudarewicz A, Zamojska-Daniszewska M, Zaborowski K, Rutkowska-Kaczmarek P. Noise exposure and hearing status among call center operators. Noise Health. 2018 Sep-Oct;20(96):178-189. doi: 10.4103/nah.NAH_11_18.
PubMed 30516171
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiologic Assessment of Call Center Operators
- ClinicalTrials.gov ID
- NCT05728203
- Acronym / sponsor ID
- Audiologic Assessment
- Conditions
- Hearing Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 15 Feb 2023 (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.
- Early detection of hearing affection in call center operators
- Study the effect of this type of noise on the auditory brainstem response.
Detailed description
Occupational noise-induced hearing loss (ONIHL) is a common occupational disease as it is estimated that 1.3 billion people were suffering of hearing loss due to noise exposure. Worldwide, occupational noise exposure is responsible for 16% of cases of disabling hearing loss in adults Commonly, hearing loss interferes with communication and can hinder personal attention and cognition. Older people with mild hearing loss have a twofold increased risk of dementia, whereas those with severe hearing loss have a fivefold increased risk of dementia.
In the last years there was increase in the number of new forms of workplaces, such as call centers. In accordance with the British Health and Safety Executive, a call center is defined as a work environment where all basic employee's tasks are completed simultaneously by phone and on PC. The very first call centers appeared in Europe in Sweden, in the mid-70's of the last century. The last decade brought rapid development of call centers proven by 10percent growth in employment in this sector between 2002and 2007.
Sources of noise occurring in offices can be divided into four categories:
- human activity (for example: noise created by walking people, phone calls including speaker systems),
- office equipment (for example: computers, printers, copy machines, faxes , ringing phones , net devices, mobile headsets),
- building indoor installations (for example: ventilation , heating system and air condition system-HVAC.hydraulic and lift systems),
- outdoor noise (most often a result of traffic).
There are many factors that have impact on indoor noise level such as outside area noise ,neighbor workers from the side as well as from the upper and lower levels activity and finally ,the call center technical equipment, The loudest systems with regard to the last one are ventilation and air condition, in accordance to research , the level of background noise is not high (54-60db) and should not be considered to be a threat towards health ;however, due to focusing employee's involuntary attention on information delivered by noise ,it should be seen as an annoying factor.
To minimize negative auditory health effects on workers in call centers, it is important to assess, and diagnose early occupational hearing loss (OHL) and tinnitus among them. As, early reporting, diagnosis, and intervention can limit the severity of, OHL as it is mostly irreversible. To our knowledge no local previous studies were done in this area.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Active working workers in call centers with minimum exposure 2year. * Had no previous auditory problems. * Their ages between [18-50] years old working at call centers from 6-12hours/day,5-6days a week.
Key inclusion criteria (3 listed)
- Active working workers in call centers with minimum exposure 2year.
- Had no previous auditory problems.
- Their ages between [18-50] years old working at call centers from 6-12hours/day,5-6days a week.
Key exclusion criteria (3 listed)
- evidence of systemic illness [ cardiovascular, renal and diabetes]
- previous history of hearing loss and tinnitus before working at the call center.
- History of noise, ototoxic drugs and chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Audiologic assessment of call center operators
Time frame: through study completion, an average 2 years
By using of audiometer to assess hearing loss and using of auditory brainstem response to assess effect of this type of noise on hearing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 30516171Pawlaczyk-Luszczynska M, Dudarewicz A, Zamojska-Daniszewska M, Zaborowski K, Rutkowska-Kaczmarek P. Noise exposure and hearing status among call center operators. Noise Health. 2018 Sep-Oct;20(96):178-189. doi: 10.4103/nah.NAH_11_18.
- Individual participant dataSharing planned: Undecided
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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.
Eman A Sayed study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Disorders, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Y Abdelrahman (01016744133, Ayayasserr1611@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiologic assessment of call center operators (time frame: through study completion, an average 2 years). 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 NCT05728203, 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 29 Mar 2023.