Hearing Loss, Noise-InducedFLIGHT-EARNCT07200310
Hearing/ET/Vestibular in Balloon Pilots
An observational study of Hearing Loss, Noise-Induced and Eustachian Tube Dysfunction, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced, Eustachian Tube Dysfunction, Vestibular Disorders
- What is being tested?
- Non-invasive audiologic and vestibular assessments
- How many people
- 105 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Sep 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Department of Otorhinolaryngology-Head & Neck Surgery (ENT/Audiology Laboratory)
Istanbul, 34108
Cappadocia Field Site (Göreme) - On-site assessments at hot-air balloon pilot companies
Nevşehir, Göreme, 50200
About this study
Official title: Hearing and Eustachian/Vestibular Functions in Hot Air Balloon Pilots: A Cross-sectional Matched-Control Study
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
Read more
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.
Read the 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 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
- Hearing Loss, Noise-Induced, Eustachian Tube Dysfunction, Vestibular Disorders, Occupational Exposure
- Being tested
- Non-invasive audiologic and vestibular assessments
- 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
- Medical subject headings
- Hearing Loss, Noise-Induced, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive audiologic and vestibular assessmentsOther
Also called Audiologic and vestibular test battery, Hearing and balance function tests, Audiologic evaluations, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Non-invasive audiologic and vestibular assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline, single visit (~5 minutes)
Secondary outcomes (7)
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.
Measured: At baseline, single visit (~3 minutes)
Pure-Tone Audiometry thresholds
Air-conduction thresholds at standard clinical frequencies and high frequencies. Hypothesis: higher thresholds in pilots.
Measured: At baseline, single visit
Cervical Vestibular Evoked Myogenic Potential (cVEMP) parameters
cVEMP amplitude and latency measured bilaterally. Hypothesis: altered responses in pilots.
Measured: At baseline, single visit
Acoustic Reflex Thresholds
Lowest sound level (dB HL) eliciting stapedius reflex, when measurable.
Measured: 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)
Measured: During balloon flight, single observation (~60-90 minutes)
Tinnitus Handicap Inventory (THI) score
Self-reported tinnitus-related handicap, total score (0-100).
Measured: Baseline, single visit
Berg Balance Scale (BBS) score
Self-reported balance function, 14-item scale (0-56).
Measured: Baseline, single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start4 Sep 2025
- Primary completion20 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Noise-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ethem İlhan, MD, Principal investigator, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital (Istanbul, Turkey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200310
- Sponsor's protocol ID
- Cappadoc-baloon-odio
- Acronym
- FLIGHT-EAR
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34840034Sahin 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.
PubMed 37992408
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing and Eustachian/Vestibular Functions in Hot Air Balloon Pilots: A Cross-sectional Matched-Control Study
- ClinicalTrials.gov ID
- NCT07200310
- Acronym / sponsor ID
- FLIGHT-EAR / Cappadoc-baloon-odio
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot-Air Balloon Pilots | – | Other: Non-invasive audiologic and vestibular assessmentsLicensed, 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 | – | Other: Non-invasive audiologic and vestibular assessmentsAge (≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive audiologic and vestibular assessmentsAlso: Audiologic and vestibular test battery, Hearing and balance function tests, Audiologic evaluations, Vestibular assessmentsstandardized, 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. | Other | Control Group, Hot-Air Balloon Pilots |
Primary outcome
Eustachian Tube Function (ΔTPP after Valsalva/Toynbee)
Time frame: 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
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Tympanometry middle-ear pressure (TPP) and compliance
Time frame: At baseline, single visit (~3 minutes)
Pure-Tone Audiometry thresholds
Time frame: At baseline, single visit
Cervical Vestibular Evoked Myogenic Potential (cVEMP) parameters
Time frame: At baseline, single visit
Acoustic Reflex Thresholds
Time frame: At baseline, single visit
In-field noise metrics during balloon operation (exploratory)
Time frame: During balloon flight, single observation (~60-90 minutes)
Tinnitus Handicap Inventory (THI) score
Time frame: Baseline, single visit
Berg Balance Scale (BBS) score
Time frame: Baseline, single visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 34840034Avci 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.
- Results publication: PubMed 37992408Sahin 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethem İlhan, MD principal investigator
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital (Istanbul, Turkey)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Noise-Induced and Eustachian Tube Dysfunction, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eustachian Tube Function (ΔTPP after Valsalva/Toynbee) (time frame: At baseline, single visit (~5 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07200310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.