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

NCT ID: NCT04681196

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-06-01

Brief Summary

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.

Detailed Description

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

The treatment of OSA with CPAP was first proposed by Sullivan et al and traditionally delivered using a nasal mask because the pressure applied through the nose would be transmitted as a pneumatic splint to the back of the upper airway and would push them anteriorly.

However patients with OSA frequently present nasal obstruction and leakage of air from the mouth, and different mask interfaces have been developed, including the oronasal mask that may be used to deliver CPAP.

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 .

In our clinical practice, CPAP titration is started adapting the patient to a nasal mask but an oronasal can be selected if a patient reports inability to breathe through their nose, severe nasal obstruction, leakage of air from the mouth or from other part of the face due to anatomical variation.

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. One recent randomised trial and a preliminary report suggest that subjects with sleep apnea treated with CPAP showed a significantly lower residual AHI when subjects wore a nasal mask rather than a oronasal mask.

Similarly, a recent prospective observational cohort study suggested that the use of a facial mask was associated with higher CPAP pressure requirements than both nasal masks and nasal pillows.

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.

These findings have been called "the Starling paradox effect", according to which the pressure that opens the pharynx can also lead to pharyngeal collapse when applied orally.

In these difficult-to-titrate patients the 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.

Conditions

Osa Syndrome

Keywords

OSAS; CPAP; nasal mask; oronasal mask

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients affected by OSA treated with CPAP / paradox effect group

patients with obstructive sleep apnea, exhibiting persistent obstructive events and paradoxical obstruction when wearing oronasal masks during CPAP, that were fully recovered with the shift to nasal one with the same or also lower pressure

patients shifted to nasal mask after persistent OSA with oronasal mask

Intervention Type: OTHER

In this group were selected OSA patients exhibiting persistent obstructive events and paradoxical obstruction with oronasal masks during CPAP , that were fully recovered (no more OSA detected) with the shift to nasal one

patients affected by OSA treated with CPAP / control group (no paradox effect)

patients with obstructive sleep apnea, with no obstructive events when wearing oronasal masks during CPAP

No interventions assigned to this group

Interventions

patients shifted to nasal mask after persistent OSA with oronasal mask

In this group were selected OSA patients exhibiting persistent obstructive events and paradoxical obstruction with oronasal masks during CPAP , that were fully recovered (no more OSA detected) with the shift to nasal one

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• confirmed diagnosis of OSA and use of CPAP treatment
• age> or equal to 18 years old
• sign of informed consent

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Francesco Tavalazzi

Francesco Tavalazzi Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero Universitaria Policlinico S. Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Other Identifiers

195/2020/Oss/AOUBO

Identifier Type: -

Identifier Source: org_study_id