NCT00694486

Brief Summary

This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 28, 2019

Status Verified

September 1, 2010

Enrollment Period

2.5 years

First QC Date

June 5, 2008

Last Update Submit

February 26, 2019

Conditions

Otitis

Keywords

otitisEustachian tube functionNormal middle ear status

Outcome Measures

Primary Outcomes (1)

  • Eustachian tube function testing results

    up to 3 months

Study Arms (1)

1

Healthy adult volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • \>18 years old
  • Normal middle-ear status

You may not qualify if:

  • Chronic illness including asthma, pulmonary, or cardiac problems
  • Pregnancy
  • \>10 dB hearing loss in any of the speech frequencies
  • Past history of sensitivity or allergic reaction to lidocaine or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • William J Doyle, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 10, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 28, 2019

Record last verified: 2010-09

Locations

US(1)