NCT02384681

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 5, 2015

Last Update Submit

March 9, 2015

Conditions

Keywords

Speech intelligibilityShort-term memoryWorking memoryPerceived mental task load

Outcome Measures

Primary Outcomes (1)

  • Change in speech intelligibility

    Before and after the 12-hour auditory exposure

Secondary Outcomes (3)

  • Change in perceived mental task load

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

  • Change in short-term memory

    Before and after the 12-hour auditory exposure

  • Change in working memory

    Before and after the 12-hour auditory exposure

Study Arms (2)

Exposed

Medical regulation assistants working with headset

Other: Exposure to auditory fatigue

Non-Exposed

Participants working without headset

Interventions

12-hour auditory exposure

Exposed

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical regulation assistants working with or without headset

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Speech Intelligibility

Condition Hierarchy (Ancestors)

SpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • Parietti-Winkler Cécile, MD, PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Parietti-Winkler Cécile, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor - Hospital Practitioner

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 10, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations