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Status unknownNCT02384681EchoSamUpdated Mar 10, 2015

Evaluation of Auditory Fatigue in Medical Regulation Assistants

An observational study in Auditory Fatigue, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

02

Conditions studied

  • Auditory Fatigue

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Keywords

  • Speech intelligibility
  • Short-term memory
  • Working memory
  • Perceived mental task load
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 36 is below the median of 100 across 367 observational studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Medical regulation assistants working with or without headset

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No

Groups and cohorts

  • Exposed

    Medical regulation assistants working with headset

    Other: Exposure to auditory fatigue

  • Non-Exposed

    Participants working without headset

Interventions

  • OtherExposure to auditory fatigue

    12-hour auditory exposure

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What researchers measure

Primary outcomes

  1. Change in speech intelligibility

    Time frame: Before and after the 12-hour auditory exposure

Secondary outcomes

  1. Change in perceived mental task load

    Time frame: During (after 2-hour auditory exposure) and after the 12-hour auditory exposure

  2. Change in short-term memory

    Time frame: Before and after the 12-hour auditory exposure

  3. Change in working memory

    Time frame: Before and after the 12-hour auditory exposure

07

Study locations

1 site
  • University Hospital of Nancy
    Nancy, 54000, France
    • Cécile Parietti-Winkler, MD, PhD · Contact · c.parietti@chu-nancy.fr · +33 383 852 032
    • Lionel Nace, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02384681
Lead sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine, Institut National de Recherche et de Sécurité, Nancy, France
Responsible party
Cecile PARIETTI-WINKLER (University Professor - Hospital Practitioner, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 10, 2015
Start date
Mar 2015
Primary completion
Oct 2015 (estimated)
Completion
Mar 2016 (estimated)
Last update
Mar 10, 2015

Study contacts

Parietti-Winkler Cécile, MD, PhD
Contact
c.parietti@chu-nancy.fr
+33 383 852 032
Parietti-Winkler Cécile, MD, PhD
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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