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NCT01925495
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3
EARLY_PHASE1 trial testing varied middle-ear pressure in Middle-ear Function in 32 participants. Terminated before completion.
12 November 2018
Quick facts
| Lead sponsor | Cuneyt M. Alper |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 2 December 2016 |
| Primary completion | 12 November 2018 |
| Estimated completion | 17 January 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- varied middle-ear pressure
- varied middle-ear gas composition — full drug profile →
- varied ear-canal pressure
Conditions studied
- Middle-ear Function — all drugs for Middle-ear Function →
Sponsor
Cuneyt M. Alper — full company profile →
Who can join
Adults 18 to 50, any sex, with Middle-ear Function. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a study to determine if there are reflexes that detect changes in eardrum position or in the pressure of middle-ear gases and respond with changes in the ease by which the Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles that surround the tube. If the Eustachian tube does not open frequently enough, the pressure in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its pressure. There is some evidence that the changes in eardrum position and middle-ear pressure when the Eustachian tube does not open frequently enough can be detected by the brain that, in turn, sends signals to the Eustachian tube and its muscles to make Eustachian tube opening easier. In this study, we will test this possibility. Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and out, apply different pressures to the middle ear, or change the composition of the gases in the middle ear while we measure how difficult it is to open the Eustachian tube by increasing middle-ear pressure or by measuring the "readiness" of the Eustachian tube muscles to contract and open the tube.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01925495
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Related trials
Other Cuneyt M. Alper trials
Trials by the same sponsor.
- NCT03850197 — Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing · completed
- NCT01925482 — Trans-Middle-Ear Mucosal Gas Exchange Project 1, Specific Aim 1 · Phase 1 · completed
- NCT01925729 — TransMEM Gas Exchange -- Project 1, Aim 2 · Phase 1 · completed
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 NCT01925495 (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 Cuneyt M. Alper
- Last refreshed: 17 May 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/NCT01925495.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing