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ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

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ClinicalTrials.gov Identifier: NCT04183361
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Andro Košec, MD, PhD, University Hospital "Sestre Milosrdnice"

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. 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

Condition or disease Intervention/treatment
Sensorineural Hearing Loss Noise Induced Hearing Loss Auditory Nerve; Lesion Diagnostic Test: ABR and salivary cortisone testing

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Correlation of Auditory Evoked Brainstem Response Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Group/Cohort Intervention/treatment
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

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 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

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.





Primary Outcome Measures :
  1. auditory evoked brainstem response (ABR) characteristics [ Time Frame: 1 day ]
    auditory evoked brainstem response after noise exposure

  2. salivary cortisone concentration [ Time Frame: 1 day ]
    salivary cortisone concentration after noise exposure


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183361


Locations
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Croatia
University Hospital Center Sestre milosrdnice
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital "Sestre Milosrdnice"
Investigators
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Study Director: Mihael Ries, MD, PhD Department of Otorhinolaryngology and Head and Neck Surgery

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Responsible Party: Andro Košec, MD, PhD, Consultant Otorhinolaryngologist and Head and Neck Surgeon, University Hospital "Sestre Milosrdnice"
ClinicalTrials.gov Identifier: NCT04183361    
Other Study ID Numbers: EP-ABR01
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andro Košec, MD, PhD, University Hospital "Sestre Milosrdnice":
noise
sensorineural hearing loss
ABR
cortisole
salivary
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cortisone
Anti-Inflammatory Agents