Differences in Efficacy Between Nasal and Oronasal Masks in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)

Obstructive Sleep Apnea (OSA) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01909674
• Other study ID #: 1108011845
• Status: Active, not recruiting
• Phase: N/A
• First received: July 24, 2013
• Last updated: July 26, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Weill Cornell Institutional Review Board, USA:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Switch CPAP mask type

Locations

Country	Name	City	State
United States	Weill Cornell Center for Sleep Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effectiveness of nasal versus oronasal CPAP masks	Measure the difference in residual apnea/ hypopnea index (AHI) between the oronasal and nasal masks during CPAP treatment. A total of 14 subjects have completed the protocol.	3 weeks for each mask condition	No