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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Tympanometry middle-ear pressure (TPP) and compliance | Description: Tympanometric peak pressure (TPP, daPa) and middle-ear compliance (ml) values will be obtained and compared between hot-air balloon pilots and controls. Abnormal or more negative TPP values are hypothesized in pilots with greater flight exposure, indicating possible Eustachian tube dysfunction. | At baseline, single visit (~3 minutes) |
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Inclusion Criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ethem İlhan, MD | University of Health Sciences, Gaziosmanpaşa Training and Research Hospital (Istanbul, Turkey) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cappadocia Field Site (Göreme) - On-site assessments at hot-air balloon pilot companies | Nevşehir | Göreme | 50200 | Turkey (Türkiye) | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34840034 | Result | 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. | |
| 37992408 | 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. |
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No plan to share individual participant data (IPD). The informed consent and protocol do not authorize IPD sharing, and the cohort is small and identifiable (hot-air balloon pilots in a defined region), increasing re-identification risk. Per protocol, only aggregate, de-identified results will be reported; source data remain on secure institutional servers accessible only to the study team.
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| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D006309 | Hearing |
| ID | Term |
|---|---|
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
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|
|
| Pure-Tone Audiometry thresholds | Air-conduction thresholds at standard clinical frequencies and high frequencies. Hypothesis: higher thresholds in pilots. | At baseline, single visit |
| Cervical Vestibular Evoked Myogenic Potential (cVEMP) parameters | cVEMP amplitude and latency measured bilaterally. Hypothesis: altered responses in pilots. | At baseline, single visit |
| Acoustic Reflex Thresholds | Lowest sound level (dB HL) eliciting stapedius reflex, when measurable. | At baseline, single visit |
| In-field noise metrics during balloon operation (exploratory) | LAeq, LAFmax, and LCpeak recorded for contextual analysis. During flight observations (subset only) | During balloon flight, single observation (~60-90 minutes) |
| Tinnitus Handicap Inventory (THI) score | Self-reported tinnitus-related handicap, total score (0-100). | Baseline, single visit |
| Berg Balance Scale (BBS) score | Self-reported balance function, 14-item scale (0-56). | Baseline, single visit |
| University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Department of Otorhinolaryngology-Head & Neck Surgery (ENT/Audiology Laboratory) |
| Istanbul |
| 34108 |
| Turkey (Türkiye) |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |