Evaluating Changes in Middle Ear Pressure Caused by CPAP

Not Applicable

Withdrawn

• Conditions: Eustachian Tube Disorder
• Interventions: Device: Continuous positive airway pressure

• Registration Number: NCT02882022
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Age >18
• No use of CPAP within past 30 days
• Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP	Continuous positive airway pressure	All participants will be included in this arm, and CPAP will be administered using a full face mask at incrementally increasing pressures. This will occur during a single session lasting no more than one hour.

Primary Outcome Measures

Name	Time	Method
Tympanometry	1 minute	Probes in the ear canal evaluate middle ear pressure

Secondary Outcome Measures

Name	Time	Method
Otoscopy	1 minute	An image of the ear drum is captured
Subjective sensation	1 minute	Patient reports if they felt their ears "pop"
Subjective symptom score	1 minute	A simple 7 question form regarding ear symptoms over the past month prior to trial involvement

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States