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Search / Trial NCT04183361

ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

Launched by UNIVERSITY HOSPITAL SESTRE MILOSRDNICE · Nov 27, 2019

Trial Information

Current as of June 27, 2025

Unknown status

Keywords

Noise Sensorineural Hearing Loss Abr Cortisole Salivary

ClinConnect Summary

The research is cross-sectional. The expected duration of the survey is at least 18 months. Assuming that the characteristics of the auditory evoked brainstem potentials are correlated with salivary cortisone concentration with a correlation coefficient of 0.4, a test power of 80% and a significance level of α = 0.05, at least 46 subjects should be included in the study. Test power analysis was performed using MedCalc Statistical Software, version 19.1 (MedCalc Software bv, Ostend, Belgium; https://www.medcalc.org; 2019). According to the data distribution (Kolmogorov-Smirnov test), appropr...

Gender

ALL

Eligibility criteria

  • 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

About University Hospital Sestre Milosrdnice

University Hospital Sestre Milosrdnice is a leading healthcare institution located in Zagreb, Croatia, renowned for its commitment to advanced medical research and high-quality patient care. The hospital serves as a pivotal center for clinical trials and innovative therapeutic approaches, leveraging its multidisciplinary expertise to enhance patient outcomes and contribute to the global medical community. With a strong emphasis on ethical standards and regulatory compliance, the institution fosters collaboration among researchers, healthcare professionals, and academic partners, aiming to translate scientific discoveries into effective treatments and improve healthcare practices.

Locations

Zagreb, , Croatia

Patients applied

0 patients applied

Trial Officials

Mihael Ries, MD, PhD

Study Director

Department of Otorhinolaryngology and Head and Neck Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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