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OpenTrials
Completed

NCT Number: NCT01909674

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Center for Sleep Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Switch CPAP mask type

Device

Primary outcomes

  1. Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2013
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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