- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02384681
Evaluation of Auditory Fatigue in Medical Regulation Assistants (EchoSam)
Effects of Auditory Fatigue in Medical Regulation Assistants Working With Headset: Objective Measures
Auditory monitoring of employees is currently based on pure-tone audiometry. However, this clinical examination does not prevent from deafness but established it a posteriori. From a preventive standpoint, it is important to detect hearing professional pain before the development of irreversible(s) clinical(s) symptom(s). The investigators' hypothesis is that auditory fatigue results from damages of primary and secondary central auditory pathways involving cognitive processes.
The assessment of auditory fatigue includes the evaluation of speech intelligibility, short-term memory, working memory and perceived mental task load. The main objective of this study is to identify, among regulating medical assistants working with headset, a central auditory fatigue.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Parietti-Winkler Cécile, MD, PhD
- Phone Number: +33 383 852 032
- Email: c.parietti@chu-nancy.fr
Study Locations
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-
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Nancy, France, 54000
- University Hospital of Nancy
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Contact:
- Cécile Parietti-Winkler, MD, PhD
- Phone Number: +33 383 852 032
- Email: c.parietti@chu-nancy.fr
-
Sub-Investigator:
- Lionel Nace, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants without hearing loss and without ontological antecedents in the past 5 years
- Participants gave their written informed consent
- Participants are affiliated to the french social welfare
- Preliminary clinical examination
Exclusion Criteria:
- Ontological antecedents in the past 5 years
- Pathology of the external or middle ear
- Abnormality in audiometric examination
- Participants already enrolled in an other research protocol
- Participants covered by articles L.1121-5 à L.1121-8 et L.1122-1-2 of the French Public Health Code
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Exposed
Medical regulation assistants working with headset
|
12-hour auditory exposure
|
Non-Exposed
Participants working without headset
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in speech intelligibility
Time Frame: Before and after the 12-hour auditory exposure
|
Before and after the 12-hour auditory exposure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in perceived mental task load
Time Frame: During (after 2-hour auditory exposure) and after the 12-hour auditory exposure
|
During (after 2-hour auditory exposure) and after the 12-hour auditory exposure
|
Change in short-term memory
Time Frame: Before and after the 12-hour auditory exposure
|
Before and after the 12-hour auditory exposure
|
Change in working memory
Time Frame: Before and after the 12-hour auditory exposure
|
Before and after the 12-hour auditory exposure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parietti-Winkler Cécile, MD, PhD, Central Hospital, Nancy, France
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A01904-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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