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NCT01976429
Gas Supply, Demand and Middle Ear Gas Balance -- Fly/Dive Simulation
NA trial testing flight/diving simulation in Middle-ear Barotrauma in 92 participants. Completed in 4 December 2018.
4 December 2018
Quick facts
| Lead sponsor | University of Pittsburgh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 92 |
| Start date | 2 December 2014 |
| Primary completion | 4 December 2018 |
| Estimated completion | 4 December 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- flight/diving simulation
- ET function testing at ambient pressure
- nasal video-endoscopy
Conditions studied
- Middle-ear Barotrauma — all drugs for Middle-ear Barotrauma →
Sponsor
University of Pittsburgh
Who can join
Adults 10 to 50, any sex, with Middle-ear Barotrauma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will determine if newly developed and more standard tests of Eustachian tube function can identify those persons who have ear pain (barotrauma) or develop middle-ear inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure as, for example, during airplane flights or scuba diving. Up to 150 adults and children (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop middle-ear fluid during those activities and approximately 60 adults and children who fly or dive but do not experience these problems will undergo Eustachian tube function testing during simulated flight and diving.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01976429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01976429 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
- Last refreshed: 7 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01976429.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing