Hearing and Eustachian/Vestibular Functions in Hot Air Balloon Pilots: A Cross-sectional Matched-Control Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Turkey
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Department of Otorhinolaryngology-Head & Neck Surgery (ENT/Audiology Laboratory)
RECRUITING
Istanbul
Cappadocia Field Site (Göreme) - On-site assessments at hot-air balloon pilot companies
RECRUITING
Nevşehir
Contact Information
Primary
Ethem İlhan, MD
ethem.ilhan@sbu.edu.tr
+90 505 591 86 50
Backup
Gökhan Yaz, MSc (Audiology)
gokhnyaz@gmail.com
+90 535 893 77 76
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 90
Treatments
Hot-Air Balloon Pilots
Licensed, professional and actively flying hot-air balloon pilots (≥18 years) 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.~Participants undergo a single non-invasive laboratory session including, tympanometry, tympanometry with maneuvers (Valsalva/Toynbee) for Eustachian tube function, pure-tone audiometry, otoacoustic emission (OAE) testing, acoustic reflex thresholds, and cervical vestibular evoked myogenic potential (cVEMP). No drugs, devices, or biospecimens are used.
Control Group
Age (≥18 years) without occupational or recreational exposure to noise, altitude, or barometric pressure changes. Participants undergo the same single non-invasive laboratory session as the pilot group (tympanometry, pure-tone audiometry, OAE tests, acoustic reflex thresholds, and cVEMP). No drugs, devices, or biospecimens are used.
Sponsors
Leads: Gaziosmanpasa Research and Education Hospital

This content was sourced from clinicaltrials.gov

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