NCT02882022

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

August 24, 2016

Last Update Submit

March 3, 2022

Conditions

Eustachian Tube Disorder

Keywords

Eustachian tube dysfunctionAudiometry

Outcome Measures

Primary Outcomes (1)

  • Tympanometry

    Probes in the ear canal evaluate middle ear pressure

    1 minute

Secondary Outcomes (3)

  • Subjective sensation

    1 minute

  • Subjective symptom score

    1 minute

  • Otoscopy

    1 minute

Study Arms (1)

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.

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressureDEVICE

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.

Also known as: CPAP
CPAP

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • No use of CPAP within past 30 days
  • Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy

You may not qualify if:

  • Pre-existing cardiopulmonary disease that presents a risk with CPAP use
  • Inability to tolerate CPAP
  • Recent otologic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related 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.

    PMID: 26485439BACKGROUND

  • 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.

    PMID: 21144374BACKGROUND

  • 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.

    PMID: 6342458BACKGROUND

  • 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.

    PMID: 22252535BACKGROUND

  • 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.

    PMID: 23553241BACKGROUND

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

US(1)