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

NCT01909674 | Completed Results

• 1 other identifier: 1108011845
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oronasal Mask

EXPERIMENTAL

Initial administration of oronasal CPAP mask

Device: Switch CPAP mask type

Nasal Mask

EXPERIMENTAL

Initial administration of nasal CPAP mask

Device: Switch CPAP mask type

Interventions

Switch CPAP mask type DEVICE

Nasal Mask; Oronasal Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with ≥ 50% central apneas

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Center for Sleep Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Matthew Ebben
• Organization: Weill Cornell Medical College

mae2001@med.cornell.edu

6469629318

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Locations

US (1)