ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

NCT04183361 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-12-05

No results posted yet for this study

Summary

The aim of the research:

Investigate the association of auditory evoked brainstem response characteristics with salivary cortisone concentrations in noise-exposed workers.

Purpose of the research:

1. Investigate the magnitude of the amplitudes and latencies of auditory brainstem responses.
2. Investigate the concentration of cortisone in saliva.
3. To investigate the correlation of the characteristics of auditory evoked brainstem potentials with the age of the subjects or the length of work in noise.
4. Investigate the association of salivary cortisone concentration with subjects' age or length of work in noise.
5. Investigate the prevalence of mild, moderate and severe hearing impairment in the 19-35 age group.
6. Investigate the relationship of hearing threshold shift with the age of the subjects or the length of work in noise.
7. To investigate the difference in the characteristics of auditory evoked brainstem potentials and the difference in salivary cortisone concentration between subjects with a bilaterally normal hearing threshold (≤25 dB) at high frequencies and subjects with unilaterally or bilaterally increased hearing threshold (\> 25 dB) at high frequencies .
8. Investigate the perceived stress and psychosocial risk factors in the workplace and their relationship to salivary cortisone concentrations.

Research Hypothesis:

There is an association between the characteristics of auditory evoked brainstem response and salivary cortisone concentrations in noise-exposed workers.

Research participants

Inclusion criteria:

1. male and female
2. ages 19-35
3. exposure to noise level ≥ 85 dB (A) per week at the workplace
4. work in noise from 1 to 16 years
5. workplace not involving exposure to carbon disulfide or a mixture of organic solvents that have toxic effects on the ear (toluene, xylene and styrene)
6. unilaterally or bilaterally normal otoscopic findings
7. unilaterally or bilaterally tympanogram: peak pressure value ± 50 daPa at 226 Hz with eardrum mobility of 0.3 to 1.3 mL

Exclusion criteria:

1. information about an earlier sudden hearing loss
2. information on chronic middle ear inflammation
3. information on ear surgery (except placement of ventilation tubes in the eardrum)
4. information on dizziness associated with hearing loss and noise
5. information on insomnia
6. current use of oral corticosteroids
7. bilaterally found air-bone gap greater than 15 dB

Conditions

  • Sensorineural Hearing Loss
  • Noise Induced Hearing Loss
  • Auditory Nerve; Lesion

Interventions

DIAGNOSTIC_TEST

ABR and salivary cortisone testing

Three saliva samples at the workplace will be collected immediately after the morning shift. The first saliva sample was given 3 days (Tuesday) before arrival at the research place, the second sample 2 days (Wednesday) before arrival, and the third sample 1 day (Thursday) before arrival at the research site. One hour before saliva sampling, a respondent should not brush his/her teeth nor eat nor drink. Fifteen minutes prior to sample administration, the subject should rinse his/her mouth with a cold water. Samples will be analyzed using High Performance Liquid Chromatography (HPLC) at the Translational Medicine Division of the Srebrnjak Children's Hospital. 2\. Collaboration in the process of assessing hearing health at the research place. The assessment includes: otoscopy, tympanometry and audiometry. Subjects will be tested for auditory evoked brainstem response in only one ear, with a more regular hearing threshold.

Sponsors & Collaborators

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Mihael Ries, MD, PhD · Department of Otorhinolaryngology and Head and Neck Surgery

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-11-01
Completion
2020-11-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183361 on ClinicalTrials.gov