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Hearing/ET/Vestibular in Balloon Pilots

NCT07200310 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2026-01-21

No results posted yet for this study

Summary

This study looks at whether working as a hot-air balloon pilot-being exposed to burner noise, changes in air pressure/temperature, and vertical acceleration-is linked to changes in hearing, Eustachian tube function, and vestibular (balance) function. Adult pilots from Cappadocia will be compared with adults who do not have these exposures.

Approximately 90 participants are expected to be enrolled For contextual exposure information, representative in-field noise measurements during balloon operations and basic flight parameters may be documented

Each participant will attend one visit (\~60 minutes) in an ENT/audiology laboratory. After a short questionnaire and an ear exam (otoscopy), the following non-invasive tests will be performed: tympanometry; tympanometry with simple maneuvers (Valsalva/Toynbee) to evaluate Eustachian tube function (ΔTPP); pure-tone audiometry (including extended high frequencies); otoacoustic emission tests (TEOAE and DPOAE); acoustic (stapedius) reflex thresholds; and a brief cervical vestibular evoked myogenic potential (cVEMP) test. Symptom-triggered questionnaires will also be used: for participants reporting tinnitus, the Tinnitus Handicap Inventory (THI); for those reporting dizziness, the Berg Balance Scale (BBS).

No medications or blood tests are involved. Testing is safe and routinely used in clinical care. Risks are minimal (for example, temporary ear-canal pressure or brief dizziness). Testing will be stopped if any discomfort occurs. Personal information will be kept confidential, and results will be reported only in group form. Findings from this study may help improve occupational health guidance for hot-air balloon pilots.

Conditions

  • Hearing Loss, Noise-Induced
  • Eustachian Tube Dysfunction
  • Vestibular Disorders
  • Occupational Exposure

Interventions

OTHER

Non-invasive audiologic and vestibular assessments

standardized, single-session test battery performed in a sound-treated clinical laboratory. Procedures include tympanometry, tympanometry with simple maneuvers (Valsalva/Toynbee) for Eustachian tube function, pure-tone audiometry, otoacoustic emission (OAE) testing, acoustic reflex thresholds, and cervical vestibular evoked myogenic potentials (cVEMP) with EMG monitoring for adequate sternocleidomastoid activation. Testing is non-invasive, takes \~60 minutes, and is conducted under routine clinical practice conditions. No investigational drugs, devices, or biospecimens are used.

Sponsors & Collaborators

  • Gaziosmanpasa Research and Education Hospital

    lead OTHER_GOV

Principal Investigators

  • Ethem İlhan, MD · University of Health Sciences, Gaziosmanpaşa Training and Research Hospital (Istanbul, Turkey)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2025-10-20
Completion
2025-11-30

Countries

  • Turkey (Türkiye)

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 NCT07200310 on ClinicalTrials.gov