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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

Tracking Information
First Submitted Date  ICMJE August 24, 2016
First Posted Date  ICMJE August 29, 2016
Last Update Posted Date May 11, 2018
Study Start Date  ICMJE August 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
Tympanometry [ Time Frame: 1 minute ]
Probes in the ear canal evaluate middle ear pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Changes in Middle Ear Pressure Caused by CPAP
Official Title  ICMJE Evaluating Changes in Middle Ear Pressure Caused by CPAP
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Eustachian Tube Disorder
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Continuous positive airway pressure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2016)
31
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02882022
Other Study ID Numbers  ICMJE 19158
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bradley Kesser, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Virginia
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP