Clinical Trial

Hearing/ET/Vestibular in Balloon Pilots

Study acronym: FLIGHT-EAR
Completed
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-27; most recent amendment 2026-01-19.
Status change: Recruiting → Completed 2026-01-19
Trial Details
NCT Number NCT07200310
Lead Sponsor Gaziosmanpasa Research and Education Hospital
Conditions Hearing Loss, Noise-Induced, Eustachian Tube Dysfunction, Vestibular Disorders, Occupational Exposure
Enrollment 105 participants
Start Date 2025-09-04
Primary Completion 2025-10-20 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-21