Evaluation of Auditory Fatigue in Medical Regulation Assistants

Auditory Fatigue Clinical Trial

— EchoSam  

Official title:

Effects of Auditory Fatigue in Medical Regulation Assistants Working With Headset: Objective Measures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02384681
• Other study ID #: 2014-A01904-43
• Status: Not yet recruiting
• Phase: N/A
• First received: March 5, 2015
• Last updated: March 9, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Central Hospital, Nancy, France
• Contact: Parietti-Winkler Cécile, MD, PhD
• Phone: +33 383 852 032
• Email: c.parietti[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Auditory Fatigue
• Fatigue

Intervention

Other:
• Exposure to auditory fatigue
12-hour auditory exposure

Locations

Country	Name	City	State
France	University Hospital of Nancy	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Institut National de Recherche et de Sécurité, Nancy, France, University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in speech intelligibility		Before and after the 12-hour auditory exposure	No
Secondary	Change in perceived mental task load		During (after 2-hour auditory exposure) and after the 12-hour auditory exposure	No
Secondary	Change in short-term memory		Before and after the 12-hour auditory exposure	No
Secondary	Change in working memory		Before and after the 12-hour auditory exposure	No