Hearing/ET/Vestibular in Balloon Pilots

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-04

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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. This is a cross-sectional study with a single assessment visit. The following non-invasive tests will be performed

Tympanometry.

Acoustic (stapedius) reflex thresholds.

Tympanometry with simple maneuvers (Valsalva/Toynbee) to evaluate Eustachian tube function (pressure change in the middle ear) (ΔTPP).

Pure-tone audiometry (standard clinical frequencies and extended high frequencies).

Otoacoustic emission tests (OAE), including transient-evoked (TEOAE) and distortion-product (DPOAE), with analysis including high frequencies.

Cervical vestibular evoked myogenic potential (cVEMP) (a test of inner-ear balance reflexes), administered for all participants using a standardized protocol and EMG monitoring for adequate sternocleidomastoid activation.

Symptom-triggered questionnaires:

For participants reporting tinnitus, the Tinnitus Handicap Inventory (THI) will be administered.

For participants reporting dizziness, the Berg Balance Scale (BBS) will be administered.

Testing is non-invasive and performed in a sound-treated environment per routine clinical practice. If any discomfort (e.g., significant dizziness, pain, or elevated blood pressure) occurs, the relevant test is stopped and the participant may be withdrawn from testing at the investigator's discretion. For contextual exposure information, representative in-field noise measurements, air-pressure and altitude during balloon operations and basic flight parameters may be documented where available; these are not required for participation.

Data are recorded under coded study IDs and stored on secure institutional servers with access restricted to authorized study staff. Results will be reported in aggregate to protect confidentiality.

Conditions

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Hearing Loss, Noise-Induced Eustachian Tube Dysfunction Vestibular Disorders Occupational Exposure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Non-invasive audiologic and vestibular assessments

Intervention Type 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.

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.

Non-invasive audiologic and vestibular assessments

Intervention Type 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.

Interventions

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Non-invasive audiologic and vestibular assessments

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.

Intervention Type OTHER

Other Intervention Names

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Audiologic and vestibular test battery Hearing and balance function tests Audiologic evaluations Vestibular assessments

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes