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Clinical Trials/NCT02882022
NCT02882022
Withdrawn
Not Applicable

Evaluating Changes in Middle Ear Pressure Caused by CPAP

University of Virginia1 site in 1 countryAugust 2016
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ConditionsEustachian Tube Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eustachian Tube Disorder
Sponsor
University of Virginia
Locations
1
Primary Endpoint
Tympanometry
Status
Withdrawn
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is an investigation into the effect that CPAP has on the pressure in the middle ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of CPAP pressure delivered via a full face mask. These measurements will be used to determine optimal levels of CPAP to affect individual's middle ear pressure, particularly those with negative middle ear pressure due to Eustachian tube dysfunction.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bradley Kesser, MD

Associate professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • •No use of CPAP within past 30 days
  • •Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy

Exclusion Criteria

  • •Pre-existing cardiopulmonary disease that presents a risk with CPAP use
  • •Inability to tolerate CPAP
  • •Recent otologic surgery

Outcomes

Primary Outcomes

Tympanometry

Time Frame: 1 minute

Probes in the ear canal evaluate middle ear pressure

Secondary Outcomes

  • Otoscopy(1 minute)
  • Subjective sensation(1 minute)
  • Subjective symptom score(1 minute)

Study Sites (1)

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