NCT01925495

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3.3 years until next milestone

Study Start

First participant enrolled

December 2, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

August 13, 2013

Last Update Submit

May 15, 2019

Conditions

Middle-ear Function

Keywords

otitis mediamiddle earfeedback pathwaysmiddle-ear pressure

Outcome Measures

Primary Outcomes (1)

  • EMG activity

    integrated EMG activity of tensor veli palatini muscle in response to changes in ear canal pressure and middle-ear pressure

    2 visits (Visits 2 and 6), approximately 3 weeks apart

Secondary Outcomes (1)

  • eustachian tube resistance

    3 visits, minimum 2 days apart

Study Arms (1)

healthy adults

EXPERIMENTAL

Experiment 1 -- variation of ear-canal pressure; Experiment 2 -- varied middle-ear gas compositions; Experiment 3 -- variation of middle-ear pressure

Other: varied middle-ear pressureDrug: varied middle-ear gas compositionOther: varied ear-canal pressure

Interventions

varied middle-ear pressureOTHER
healthy adults
varied middle-ear gas compositionDRUG
healthy adults
varied ear-canal pressureOTHER
healthy adults

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Otherwise healthy adults aged 18 to 50 years, inclusive
  • No history of significant ME disease
  • No history of past ME surgeries
  • Able to comprehend study risks and provide written Informed Consent

You may not qualify if:

  • Have any chronic health problem
  • Have ME fluid or otitis media (OM)at the time of presentation
  • Have drainage through the tympanostomy tube at the time of testing
  • Taking any prescription drug with the exception of those for birth control that would interfere with study per study MD
  • Have a known or suspected allergy/adverse reaction to any of the study drugs use to prepare the tympanic membrane for ventilation tube insertion or the nasopharynx for EMG needle insertion
  • Have a hearing threshold \>15 dB or a \>10 dB air-bone gap at any of the speech frequencies
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middle Ear Physiology Laboratory, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Cuneyt M Alper, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Otolaryngology

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 19, 2013

Study Start

December 2, 2016

Primary Completion

November 12, 2018

Study Completion

January 17, 2019

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)