ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

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Brief Title

ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

Official Title

Correlation of Auditory Evoked Brainstem Response Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

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
    

Detailed Description

      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), appropriate parametric and / or non-parametric
      statistical tests will be applied in accordance with the obtained results. The data will be
      presented in tables and graphs. Numerical variables will be represented using the range,
      arithmetic mean and standard deviation, respectively, the median and the interquartile range,
      in cases of distribution that does not follow the normal distribution. The categorical
      variables will be presented using absolute frequencies and their respective proportions.
      Differences in the values of the numerical variables between the test groups with a defined
      hearing threshold will be analyzed by parametric Student's t-test for independent samples,
      and non-parametric Mann-Whitney U test for independent samples. Differences in categorical
      variables between the examined groups will be analyzed by chi-square test or Fisher's exact
      test in cases where the number of subjects in each group is less than 5. The corresponding
      correlation coefficients (Pearson's or Spearman's) between individual clinical variables will
      be calculated. An appropriate regression model for the prediction of belonging to a group
      with a defined hearing threshold shift will be made, which will include those that have a
      significance level of P≤0.20 in the previous statistical analyzes. In the above tests,
      significant P values will be considered to be less than 0.05. The statistical analysis of
      data will use IBM SPSS Statistics licensed software version 25.0.

      Material:

        1. Audiometer Audiometer AC40

        2. DD45 audiometric headphones

        3. Interacoustics AZ26 tympanometer

        4. Equipment for testing auditory evoked brainstem potentials: ABR Interacoustics Eclipse,
           EPA Preamplifier, 3M E-A-RTONE Insert Earphone ABR

        5. Cortisol-Salivette Cotton Salad Carrier

        6. High Performance Liquid Chromatography (HPLC)

        7. validated questionnaire in the Croatian language - assessment of psychosocial risk
           factors in the HSE workplace 8th validated questionnaire in Croatian - The scale of
           stress experienced

      Research plan:

      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. The research
      leader, research mentors, and occupational safety manager, who is responsible for supervising
      the sampling and storage of saliva samples in the refrigerator at +4 ℃ in the workplace, know
      the password and associated name.

      A participant is expected to:

        1. Give 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. 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. Then head of
           the research analyses coded saliva samples in laboratory by using High Performance
           Liquid Chromatography (HPLC) at the Translational Medicine Division of the Srebrnjak
           Children's Hospital. After processing and preparing each of the saliva samples for HPLC,
           the native sample no longer exists. After the analytes will be detected in the isolate,
           all the material will be completely eliminated as infectious waste.

        2. Collaboration in the process of assessing hearing health at the research place. The
           assessment includes: otoscopy, tympanometry and audiometry. Subjects who do not meet
           point 6 and 7 of the inclusion criteria or who meet point 7 of the exclusion criteria
           will not be tested for auditory evoked brainstem response. Other subjects will be tested
           for auditory evoked brainstem response in only one ear, with a more regular hearing
           threshold.

        3. Self-assessment of perceived stress and psychosocial risk factors in the workplace by
           completing a questionnaire at the research site.

      A researcher conducting this research and the research participants will not receive a
      financial fee for their participation.

      Expected scientific contribution of the research:

      Quantification of the association of auditory evoked brainstem response characteristics with
      salivary cortisone concentrations among workers exposed to noise.

      Possible risks of participating in the research:

      This research involves no risk other than the usual daily risk.
    


Study Type

Observational


Primary Outcome

auditory evoked brainstem response (ABR) characteristics


Condition

Sensorineural Hearing Loss

Intervention

ABR and salivary cortisone testing

Study Arms / Comparison Groups

 Patients with noise exposure and salivary cortisone
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

100

Start Date

November 1, 2019

Completion Date

November 1, 2020

Primary Completion Date

November 1, 2020

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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mihael Ries, MD, PhD, , 

Location Countries

Croatia

Location Countries

Croatia

Administrative Informations


NCT ID

NCT04183361

Organization ID

EP-ABR01


Responsible Party

Principal Investigator

Study Sponsor

University Hospital "Sestre Milosrdnice"


Study Sponsor

Mihael Ries, MD, PhD, Study Director, Department of Otorhinolaryngology and Head and Neck Surgery


Verification Date

December 2019