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Evaluating Changes in Middle Ear Pressure Caused by CPAP

Evaluating Changes in Middle Ear Pressure Caused by CPAP

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02882022
Enrollment
0
Registered
2016-08-29
Start date
2016-08-31
Completion date
2017-07-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eustachian Tube Disorder

Keywords

Eustachian tube dysfunction, Audiometry

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.

Interventions

DEVICEContinuous positive airway pressure

A CPAP machine will be used to deliver positive pressure at various levels after which middle ear pressure and ear drums will be evaluated for changes.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \>18 * 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

Design outcomes

Primary

MeasureTime frameDescription
Tympanometry1 minuteProbes in the ear canal evaluate middle ear pressure

Secondary

MeasureTime frameDescription
Subjective sensation1 minutePatient reports if they felt their ears pop
Subjective symptom score1 minuteA simple 7 question form regarding ear symptoms over the past month prior to trial involvement
Otoscopy1 minuteAn image of the ear drum is captured

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026