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Status:

RECRUITING

Hearing/ET/Vestibular in Balloon Pilots

Lead Sponsor:

Gaziosmanpasa Research and Education Hospital

Conditions:

Hearing Loss, Noise-Induced

Eustachian Tube Dysfunction

Eligibility:

All Genders

18+ years

Brief 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...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

September 4 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 30 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT07200310

Start Date

September 4 2025

End Date

November 30 2025

Last Update

December 2 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Cappadocia Field Site (Göreme) - On-site assessments at hot-air balloon pilot companies

Nevşehir, Göreme, Turkey (Türkiye), 50200

2

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Department of Otorhinolaryngology-Head & Neck Surgery (ENT/Audiology Laboratory)

Istanbul, Turkey (Türkiye), 34108