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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: Switch CPAP mask type

• Registration Number: NCT01909674
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Study Completion: 2013-08
• Results First Submitted: 2017-02-16
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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Exclusion Criteria

• Patients with ≥ 50% central apneas

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oronasal Mask	Switch CPAP mask type	Initial administration of oronasal CPAP mask
Nasal Mask	Switch CPAP mask type	Initial administration of nasal CPAP mask

Primary Outcome Measures

Name	Time	Method
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks	3 weeks for each mask condition	Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.

Trial Locations

Locations (1)

Weill Cornell Center for Sleep Medicine; 🇺🇸 New York, New York, United States