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Evaluating Changes in Middle Ear Pressure Caused by CPAP

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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
Sponsor:
Information provided by (Responsible Party):
Bradley Kesser, MD, University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eustachian Tube Disorder Device: Continuous positive airway pressure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: CPAP
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


Outcome Measures
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Primary Outcome Measures :
  1. Tympanometry [ Time Frame: 1 minute ]
    Probes in the ear canal evaluate middle ear pressure


Secondary Outcome Measures :
  1. Subjective sensation [ Time Frame: 1 minute ]
    Patient reports if they felt their ears "pop"

  2. Subjective symptom score [ Time Frame: 1 minute ]
    A simple 7 question form regarding ear symptoms over the past month prior to trial involvement

  3. Otoscopy [ Time Frame: 1 minute ]
    An image of the ear drum is captured


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
More Information
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Publications:

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Responsible Party: Bradley Kesser, MD, Associate professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02882022    
Other Study ID Numbers: 19158
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Keywords provided by Bradley Kesser, MD, University of Virginia:
Eustachian tube dysfunction
Audiometry