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

Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Cross-over Study

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Switch CPAP mask type

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Center for Sleep Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

• Patients with ≥ 50% central apneas

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oronasal Mask; Initial administration of oronasal CPAP mask	Device: Switch CPAP mask type
Experimental: Nasal Mask; Initial administration of nasal CPAP mask	Device: Switch CPAP mask type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks	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.	3 weeks for each mask condition

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 1108011845