Hearing LossNCT03118102
Audiological Evaluation of Anesthetists
An observational study of Hearing Loss, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators aim to investigate the effect of operating room noise on anesthetist hearing Read more about this study
- Who is it for?
- Ages 28 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2017to 8 Jan 2018
- 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 28 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: anesthetist doctor who subject to noise in operating rooms
Who may be able to join
- anesthetist doctor and non-anesthetist doctor less than 40 years
Who cannot join
- doctors above 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effects of Noise in Operating Rooms on Anesthetists Hearing
The investigators aim to investigate the effect of operating room noise on anesthetist hearing
- Conditions
- Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| anesthetist group | anesthetist doctor who subjected to noise in operating rooms | |
| control group | doctors in the same hospital who are not subjected to noise in operating rooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended high frequency audiometry
pure tone audiometry in the frequency range from 250Hz-20,000Hz
Measured: 20 minutes
Secondary outcomes (1)
Transient Evoked Otoacoustic Emission
stimulus induced cochlear echos in the frequency range from 1000-4000 Hz
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start10 Apr 2017
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled salah mohamed, Assiut University
- Investigators
- Khaled Salah Mohamed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118102
- Sponsor's protocol ID
- kmohamed
- Status last verified
- Jan 2018
- First submitted
- 9 Apr 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Noise in Operating Rooms on Anesthetists Hearing
- ClinicalTrials.gov ID
- NCT03118102
- Acronym / sponsor ID
- kmohamed
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 18 Apr 2017 (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.
The investigators aim to investigate the effect of operating room noise on anesthetist hearing
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anesthetist group | – | –anesthetist doctor who subjected to noise in operating rooms |
| control group | – | –doctors in the same hospital who are not subjected to noise in operating rooms |
Who may qualify
- Ages
- 28 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- anesthetist doctor who subject to noise in operating rooms
Key inclusion criteria (1 listed)
- anesthetist doctor and non-anesthetist doctor less than 40 years
Key exclusion criteria (1 listed)
- doctors above 40 years
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
Extended high frequency audiometry
Time frame: 20 minutes
pure tone audiometry in the frequency range from 250Hz-20,000Hz
1 secondary outcome
Transient Evoked Otoacoustic Emission
Time frame: 10 minutes
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 9 Jan 2018.
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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.
Khaled Salah Mohamed, MD principal investigator
Assiut 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 Hearing Loss, run by Assiut University at 1 site in Egypt.
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 9 Jan 2018. 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 Egypt. 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?
Extended high frequency audiometry (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018; AzTrials last refreshed its copy on 1 Nov 2026.