Auditory FatigueEchoSamNCT02384681
Evaluation of Auditory Fatigue in Medical Regulation Assistants
An observational study of Auditory Fatigue, run by Central Hospital, Nancy, France at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Fatigue
- What is being tested?
- Exposure to auditory fatigue
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical regulation assistants working with or without headset
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Nancy
Nancy, 54000
Cécile Parietti-Winkler, MD, PhD, +33 383 852 032, c.parietti@chu-nancy.fr
Lionel Nace, MD
About this study
Official title: 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.
- Conditions
- Auditory Fatigue
- Being tested
- Exposure to auditory fatigue
- Keywords
- Speech intelligibility, Short-term memory, Working memory, Perceived mental task load
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to auditory fatigueOther
12-hour auditory exposure
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Medical regulation assistants working with headset Receives: Other: Exposure to auditory fatigue | |
| Non-Exposed | Participants working without headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in speech intelligibility
Measured: Before and after the 12-hour auditory exposure
Secondary outcomes (3)
Change in perceived mental task load
Measured: During (after 2-hour auditory exposure) and after the 12-hour auditory exposure
Change in short-term memory
Measured: Before and after the 12-hour auditory exposure
Change in working memory
Measured: Before and after the 12-hour auditory exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory FatigueStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine, Institut National de Recherche et de Sécurité, Nancy, France
- Responsible party
- Principal investigator, Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
- Investigators
- Parietti-Winkler Cécile, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384681
- Sponsor's protocol ID
- 2014-A01904-43
- Acronym
- EchoSam
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auditory Fatigue in Medical Regulation Assistants Working With Headset: Objective Measures
- ClinicalTrials.gov ID
- NCT02384681
- Acronym / sponsor ID
- EchoSam / 2014-A01904-43
- Conditions
- Auditory Fatigue
- Keywords
- Speech intelligibility, Short-term memory, Working memory, Perceived mental task load
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine, Institut National de Recherche et de Sécurité, Nancy, France
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: Exposure to auditory fatigueMedical regulation assistants working with headset |
| Non-Exposed | – | –Participants working without headset |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical regulation assistants working with or without headset
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to auditory fatigue12-hour auditory exposure | Other | Exposed |
Primary outcome
Change in speech intelligibility
Time frame: Before and after the 12-hour auditory exposure
3 secondary outcomes
Change in perceived mental task load
Time frame: 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
Change in working memory
Time frame: Before and after the 12-hour auditory exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
Related trials for Auditory Fatigue
Not yet recruiting
Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)
D001305, Auditory Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parietti-Winkler Cécile, MD, PhD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auditory Fatigue, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Parietti-Winkler Cécile, MD, PhD (+33 383 852 032, c.parietti@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speech intelligibility (time frame: Before and after the 12-hour auditory exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.