Evaluating Changes in Middle Ear Pressure Caused by CPAP
NCT ID: NCT02882022
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-08-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No use of CPAP within past 30 days
* Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy
Exclusion Criteria
* Inability to tolerate CPAP
* Recent otologic surgery
18 Years
MALE
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Bradley Kesser, MD
Associate professor
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Akbulut S, Demir MG, Salepci BM, Gungor GA, Demir N, Berk D, Cakan D. Efficacy of continuous positive airway pressure on middle ear atelectasis: A double-blind placebo-controlled clinical trial. Laryngoscope. 2016 Jul;126(7):1649-55. doi: 10.1002/lary.25735. Epub 2015 Oct 20.
Aksoy F, Yildirim YS, Ozturan O, Veyseller B, Cuhadaroglu C. Eustachian tube function in patients receiving continuous positive airway pressure treatment for sleep apnea syndrome. J Otolaryngol Head Neck Surg. 2010 Dec;39(6):752-6.
Drake-Lee AB, Casey WF, Ogg TW. Anaesthesia for myringotomy. The effect of nitrous oxide and intermittent positive pressure ventilation in children with secretory otitis media. Anaesthesia. 1983 Apr;38(4):314-8. doi: 10.1111/j.1365-2044.1983.tb10451.x.
Lin FY, Gurgel RK, Popelka GR, Capasso R. The effect of continuous positive airway pressure on middle ear pressure. Laryngoscope. 2012 Mar;122(3):688-90. doi: 10.1002/lary.22442. Epub 2012 Jan 17.
Sivri B, Sezen OS, Akbulut S, Coskuner T. The effect of continuous positive airway pressure on middle ear pressure. Laryngoscope. 2013 May;123(5):1300-4. doi: 10.1002/lary.23896. Epub 2013 Apr 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19158
Identifier Type: -
Identifier Source: org_study_id
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