ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

NCT04183361 | Unknown

• 1 other identifier: EP-ABR01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Investigate the magnitude of the amplitudes and latencies of auditory brainstem responses.
2. 2.Investigate the concentration of cortisone in saliva.
3. 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. 4.Investigate the association of salivary cortisone concentration with subjects' age or length of work in noise.
5. 5.Investigate the prevalence of mild, moderate and severe hearing impairment in the 19-35 age group.
6. 6.Investigate the relationship of hearing threshold shift with the age of the subjects or the length of work in noise.
7. 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. 8.Investigate the perceived stress and psychosocial risk factors in the workplace and their relationship to salivary cortisone concentrations.
9. 9.male and female
10. 10.ages 19-35
11. 11.exposure to noise level ≥ 85 dB (A) per week at the workplace
12. 12.work in noise from 1 to 16 years
13. 13.workplace not involving exposure to carbon disulfide or a mixture of organic solvents that have toxic effects on the ear (toluene, xylene and styrene)
14. 14.unilaterally or bilaterally normal otoscopic findings
15. 15.unilaterally or bilaterally tympanogram: peak pressure value ± 50 daPa at 226 Hz with eardrum mobility of 0.3 to 1.3 mL
16. 16.information about an earlier sudden hearing loss
17. 17.information on chronic middle ear inflammation
18. 18.information on ear surgery (except placement of ventilation tubes in the eardrum)
19. 19.information on dizziness associated with hearing loss and noise
20. 20.information on insomnia
21. 21.current use of oral corticosteroids
22. 22.bilaterally found air-bone gap greater than 15 dB

Conditions

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

Keywords

noise; sensorineural hearing loss; ABR; cortisole; salivary

Outcome Measures

Primary Outcomes (2)

• auditory evoked brainstem response (ABR) characteristics

  auditory evoked brainstem response after noise exposure

  1 day

• salivary cortisone concentration

  salivary cortisone concentration after noise exposure

  1 day

Study Arms (2)

Patients with noise exposure and salivary cortisone

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

Diagnostic Test: ABR and salivary cortisone testing

Patients without noise exposure and salivary cortisone

1. male and female 2. ages 19-35 3. no 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

Diagnostic Test: ABR and salivary cortisone testing

Interventions

ABR and salivary cortisone testing DIAGNOSTIC_TEST

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.

Patients with noise exposure and salivary cortisone; Patients without noise exposure and salivary cortisone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

An employer finds workers who meet points 1-5 of study inclusion criteria. A head of the research checks their medical history and includes them in the study if they do not meet any of first six exclusion criteria. A head of the research orally informs these workers at the meeting and helps them to understand and sign a written informed consent for participation in the research. Each of them receive an information about the date of arrival at the place of research and also a unique password that encodes saliva samples, completed questionnaires and electronic and printed findings derived from the assessment of hearing health.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Three saliva samples at the workplace 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. Coded saliva samples in laboratory by using High Performance Liquid Chromatography (HPLC) at the Translational Medicine Division of the Srebrnjak Children's Hospital.

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Noise-Induced; Vestibulocochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retrocochlear Diseases; Cranial Nerve Diseases

Study Officials

• Mihael Ries, MD, PhD

  Department of Otorhinolaryngology and Head and Neck Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Otorhinolaryngologist and Head and Neck Surgeon

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)