Evaluating Changes in Middle Ear Pressure Caused by CPAP

University of Virginia

Status: Withdrawn

Conditions: Eustachian Tube Disorder

Treatments: Device: Continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02882022

19158

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

CPAP

Experimental group

Description:

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.

Treatment:

Device: Continuous positive airway pressure