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

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Switch CPAP mask type
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weill Cornell Center for Sleep Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oronasal Mask

Nasal Mask

Arm Description

Initial administration of oronasal CPAP mask

Initial administration of nasal CPAP mask

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2013
Last Updated
April 6, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01909674
Brief Title
Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of OSA With CPAP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oronasal Mask
Arm Type
Experimental
Arm Description
Initial administration of oronasal CPAP mask
Arm Title
Nasal Mask
Arm Type
Experimental
Arm Description
Initial administration of nasal CPAP mask
Intervention Type
Device
Intervention Name(s)
Switch CPAP mask type
Primary Outcome Measure Information:
Title
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks
Description
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.
Time Frame
3 weeks for each mask condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Weill Cornell Center for Sleep Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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