Evaluating Changes in Middle Ear Pressure Caused by CPAP

Eustachian Tube Disorder Clinical Trial

Official title:

Evaluating Changes in Middle Ear Pressure Caused by CPAP

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02882022
• Other study ID #: 19158
• Status: Withdrawn
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tympanometry	Probes in the ear canal evaluate middle ear pressure	1 minute
Secondary	Subjective sensation	Patient reports if they felt their ears "pop"	1 minute
Secondary	Subjective symptom score	A simple 7 question form regarding ear symptoms over the past month prior to trial involvement	1 minute
Secondary	Otoscopy	An image of the ear drum is captured	1 minute