Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

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Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oronasal Mask

Initial administration of oronasal CPAP mask

Group Type EXPERIMENTAL

Switch CPAP mask type

Intervention Type DEVICE

Nasal Mask

Initial administration of nasal CPAP mask

Group Type EXPERIMENTAL

Switch CPAP mask type

Intervention Type DEVICE

Interventions

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Switch CPAP mask type

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* previously diagnosed with OSA
* returning for PAP titrations at the Center for Sleep Medicine
* CPAP and titration naive
* Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr.