Hearing/ET/Vestibular in Balloon Pilots

NCT07200310 | Completed

• 1 other identifier: Cappadoc-baloon-odio
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

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 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

Keywords

Hot-Air Balloon Pilots; Noise Exposure; Hearing Loss; Eustachian Tube Function; Vestibular Function; cVEMP; Otoacoustic Emissions (OAE); Acoustic Reflex; Occupational Health; Altitude / Barometric Pressure

Outcome Measures

Primary Outcomes (3)

• Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)

  Tympanometric middle-ear pressure change (ΔTPP in daPa) after maneuvers will be recorded. Impaired function defined as ΔTPP ≤15 daPa.

  At baseline, single visit (~5 minutes)

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

  Mean DPOAE amplitudes at 1-12 kHz will be compared between hot-air balloon pilots and controls. Lower amplitudes are hypothesized in pilots with greater flight exposure.

  At baseline, single visit (~5 minutes)

• Transient-Evoked Otoacoustic Emission (TEOAE)

  Description: Mean TEOAE SNRs (dB) in half-octave bands from 1-4 kHz (and overall response/reproducibility %) will be compared between hot-air balloon pilots and controls. Lower SNRs are hypothesized in pilots with greater flight exposure.

  At baseline, single visit (~5 minutes)

Secondary Outcomes (7)

• Tympanometry middle-ear pressure (TPP) and compliance

  At baseline, single visit (~3 minutes)

• Pure-Tone Audiometry thresholds

  At baseline, single visit

• Cervical Vestibular Evoked Myogenic Potential (cVEMP) parameters

  At baseline, single visit

• Acoustic Reflex Thresholds

  At baseline, single visit

• In-field noise metrics during balloon operation (exploratory)

  During balloon flight, single observation (~60-90 minutes)

Study Arms (2)

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.

Other: Non-invasive audiologic and vestibular assessments

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.

Other: Non-invasive audiologic and vestibular assessments

Interventions

Non-invasive audiologic and vestibular assessments OTHER

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.

Also known as: Audiologic and vestibular test battery, Hearing and balance function tests, Audiologic evaluations, Vestibular assessments

Control Group; Hot-Air Balloon Pilots

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) in two cohorts: (1)(Hot-Air Balloon Pilots) licensed hot-air balloon pilots operating in the Cappadocia/Nevşehir region with ≥10 flights in the prior 12 months; and (2)(Controls) age-matched adults with no occupational or recreational exposure to significant noise, altitude, or barometric pressure variation (e.g., non-pilots, non-divers, non-cabin crew). Participants are healthy volunteers with otoscopic suitability (no perforation or active infection). Recruitment is via local pilot companies/registries and the surrounding community; all assessments occur at the SBÜ Gaziosmanpaşa Training and Research Hospital ENT/audiology laboratory (single-center). Planned enrollment: 45 pilots and 45 controls.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (2)

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

Nevşehir, Göreme, 50200, Turkey (Türkiye)

Location

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

Istanbul, 34108, Turkey (Türkiye)

Location

Related Publications (2)

• Avci D, Sahin MI. Are the hearing and eustachian tube functions of the hot air balloon pilots disturbed? Auris Nasus Larynx. 2022 Aug;49(4):577-583. doi: 10.1016/j.anl.2021.11.002. Epub 2021 Nov 25.

  PMID: 34840034 RESULT

• Sahin Ceylan D, Sacli Y, Gultekin G, Avsar B, Ozver AG. Do Flights Affect Hearing in Hot Air Balloon Pilots? Am J Audiol. 2023 Nov 22:1-10. doi: 10.1044/2023_AJA-23-00126. Online ahead of print.

  PMID: 37992408 RESULT

MeSH Terms

Conditions

Hearing Loss, Noise-Induced; Hearing Loss

Interventions

Hearing

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ethem İlhan, MD

  University of Health Sciences, Gaziosmanpaşa Training and Research Hospital (Istanbul, Turkey)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: October 1, 2025
• Study Start: September 4, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)