CompletedNot Applicable

Hearing/ET/Vestibular in Balloon Pilots

Turkey (Türkiye)105 participantsStarted 2025-09-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years (preferably 18-70). Pilot group: Licensed, professional and actively flying hot-air balloon pilots with regular flight over the past 12 months (on average 5 days per week and at least 20 flights in month), not using any hearing-protection equipment, and typically each flying et least 60-90 minutes. Control group: Adults without occupational or recreational exposure to significant pressure/altitude/noise (e.g., no mountaineering, scuba diving, or cabin crew duties). Otoscopic suitability for testing (no tympanic membrane perforation; no active ear infection). Exclusion Criteria: * Acute upper respiratory tract infection (URTI) or otitis at the time of testing., * High noise exposure within the past 24-48 hours (e.g., concert, workshop). * Tympanic membrane perforation; impacted cerumen that cannot be cleared; chronic suppurative otitis; presence of an active ventilation (tympanostomy) tube. * History of otologic surgery. * Menière's disease; significant otosclerosis; vestibular neuritis within the past 6 months; recent sudden hearing loss. * Significant neurological disease or history affecting balance (e.g., multiple sclerosis, stroke). * Use of ototoxic medications within the past 3 months (e.g., aminoglycosides, cisplatin). * Contraindications to cVEMP testing (e.g., significant cervical pathology or prior cervical surgery, uncontrolled hypertension, suspected advanced carotid artery disease).

What they're measuring

Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)

Timeframe: At baseline, single visit (~5 minutes)

Distortion Product Otoacoustic Emission (DPOAE) amplitudes at 1-12 kHz

Timeframe: At baseline, single visit (~5 minutes)

Transient-Evoked Otoacoustic Emission (TEOAE)

Timeframe: At baseline, single visit (~5 minutes)

Trial details

NCT IDNCT07200310

SponsorGaziosmanpasa Research and Education Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-10-20

View on ClinicalTrials.gov More Hearing Loss, Noise-Induced trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)

Timeframe: At baseline, single visit (~5 minutes)

Distortion Product Otoacoustic Emission (DPOAE) amplitudes at 1-12 kHz

Timeframe: At baseline, single visit (~5 minutes)

Transient-Evoked Otoacoustic Emission (TEOAE)

Timeframe: At baseline, single visit (~5 minutes)