Hearing and Eustachian/Vestibular Functions in Hot Air Balloon Pilots: A Cross-sectional Matched-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
结局指标
主要结局
Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)
时间窗: At baseline, single visit (~5 minutes)
Tympanometric middle-ear pressure change (ΔTPP in daPa) after maneuvers will be recorded. Impaired function defined as ΔTPP ≤15 daPa.
Distortion Product Otoacoustic Emission (DPOAE) amplitudes at 1-12 kHz
时间窗: At baseline, single visit (~5 minutes)
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.
Transient-Evoked Otoacoustic Emission (TEOAE)
时间窗: At baseline, single visit (~5 minutes)
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.
次要结局
- Berg Balance Scale (BBS) score(Baseline, single visit)
- 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))
- Tinnitus Handicap Inventory (THI) score(Baseline, single visit)