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Study closed due to lack of participants
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tympanometry | Probes in the ear canal evaluate middle ear pressure | 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sensation | Patient reports if they felt their ears "pop" | 1 minute |
| Subjective symptom score | A simple 7 question form regarding ear symptoms over the past month prior to trial involvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26485439 | Background | 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. | |
| 21144374 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2016 | Feb 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2016 | Feb 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
| 1 minute |
| Otoscopy | An image of the ear drum is captured | 1 minute |
| 6342458 | Background | 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. |
| 22252535 | Background | 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. |
| 23553241 | Background | 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. |
| D012138 |
| Respiratory Therapy |