Evaluating Changes in Middle Ear Pressure Caused by CPAP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02882022|
Recruitment Status : Terminated (Study closed due to lack of participants)
First Posted : August 29, 2016
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eustachian Tube Disorder||Device: Continuous positive airway pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Changes in Middle Ear Pressure Caused by CPAP|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
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.
Device: Continuous 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.
Other Name: CPAP
- Tympanometry [ Time Frame: 1 minute ]Probes in the ear canal evaluate middle ear pressure
- Subjective sensation [ Time Frame: 1 minute ]Patient reports if they felt their ears "pop"
- Subjective symptom score [ Time Frame: 1 minute ]A simple 7 question form regarding ear symptoms over the past month prior to trial involvement
- Otoscopy [ Time Frame: 1 minute ]An image of the ear drum is captured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882022
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|