NCT04681196

Nasal Versus Oronasal Mask in Continuous Positive Airway Pressure (CPAP) Treatment of Patients Affected by Obstructive Sleep Apnea Syndrome (OSAS).

Completed Last updated 9 November 2021

What this trial tests

trial testing patients shifted to nasal mask after persistent OSA with oronasal mask in Osa Syndrome in 61 participants. Completed in 1 June 2021.

Timeline

1 January 2021

Primary endpoint
1 March 2021

1 June 2021

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Status	Completed
Study type	OBSERVATIONAL
Enrollment	61
Start date	1 January 2021
Primary completion	1 March 2021
Estimated completion	1 June 2021
Sites	1 location across Italy

Drugs / interventions tested

• patients shifted to nasal mask after persistent OSA with oronasal mask

Conditions studied

• Osa Syndrome — all drugs for Osa Syndrome →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

18 and older, any sex, with Osa Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Continuous positive airway pressure (CPAP) is considered the gold standard treatment for patients with moderate to severe obstructive sleep apnea (OSA).

Nasal and oronasal masks are often used interchangeably and are generally believed to be equally effective; the choice of interface for OSA therapy remains largely based on clinical judgement and patients preference. However, there is increasing evidence that CPAP delivered by an oronasal mask may be less effective, requires more pressure and are worse tolerated than nasal mask. Patients with OSA on oronasal mask are also less adherent to CPAP.

Some authors have suggested that in some subjects, the CPAP was not effective when an oronasal mask was used. Moreover when pressures are increased to overcome the obstruction, a paradoxical obstruction may take place.

Specific mechanisms explaining upper-airway obstruction events remain unclear and it is not known how many patients exhibit this behavior.

This observational retrospective study is designed to compare a group of patients with obstructive sleep apnea with persistent obstructive events using oronasal masks during CPAP, that were fully recovered with the shift to nasal one with the same or also lower pressure, versus a control group of patients who did not report obstruction with oronasal masks. Aim of the study was to find differences in term of clinical, anatomical and physiological characteristics between these two groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.