Evaluation of Auditory Fatigue in Medical Regulation Assistants (EchoSam)

March 9, 2015 updated by: Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • University Hospital of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Medical regulation assistants working with or without headset

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed
Medical regulation assistants working with headset
Other: Exposure to auditory fatigue
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

University of Lorraine
Institut National de Recherche et de Sécurité, Nancy, France

Investigators

  • Principal Investigator: Parietti-Winkler Cécile, MD, PhD, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

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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