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

NCT04681196 | Completed

• 1 other identifier: 195/2020/Oss/AOUBO
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Osa Syndrome

Keywords

OSAS; CPAP; nasal mask; oronasal mask

Outcome Measures

Primary Outcomes (6)

• differences in terms of age between groups

  differences in terms of age (measured in years) between patients with paradox effect versus patients without paradox effect (control group); age considered at the time of OSA diagnosis

  Up to one month.

• differences in terms of body mass index between groups

  differences in terms of body mass index (BMI), measured in Kg/m2, between patients with paradox effect versus patients without paradox effect (control group); BMI considered at the time of OSA diagnosis.

  Up to one month.

• differences in terms of basal value of apnea-hypopnea index (OSA severity) between groups

  differences in terms of basal value of apnea-hypopnea index (OSA severity) between groups. AHI considered at the time of OSA diagnosis (basal cardio-respiratory monitoring) Apnea-hypopnea index (AHI) measures number of obstructive events (apnea and hypopnea) per hour during basal cardio-respiratory monitoring. AHI\> 5 is diagnostic of OSA. Severity of OSA is proportional to AHI value.

  Up to one month.

• differences in terms of basal value of minimum and mean nocturnal oxygen saturation between groups.

  differences in terms of basal value of minimum and mean nocturnal oxygen saturation (respectively minimum SpO2 % and mean SpO2 %) between groups.Minimum and mean Oxygen Saturation considered at the time of OSA diagnosis (basal cardio-respiratory monitoring).

  Up to one month.

• differences in terms of basal value of time spent under SpO2<90% and under SpO2<80% between groups.

  differences in terms of basal value of time spent under SpO2\<90% (CT90) and under SpO2\<80% (CT80) between groups.minimum and mean Oxygen Saturation considered at the time of OSA diagnosis (basal cardio-respiratory monitoring). These two parameters are expressed as % of total registration time during basal cardio-respiratory monitoring at the time od OSA diagnosis.

  Up to one month.

• differences in terms of oxygen desaturation index between groups.

  differences in terms of oxygen desaturation index (ODI) between groups. ODI represents number of decline of SpO2 \> or equal to 3% events per hours during basal cardio-respiratory monitoring collected at the time od OSA diagnosis.ODI considered at the time of OSA diagnosis (basal cardio-respiratory monitoring)

  Up to one month.

Study Arms (2)

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

Other: patients shifted to nasal mask after persistent OSA with oronasal mask

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

Interventions

patients shifted to nasal mask after persistent OSA with oronasal mask 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 / paradox effect group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this observational retrospetive study were selected patients affected by OSA treated with CPAP. From this population were selected patients using oronasal mask with complete recovery of OSA (AHI\<5) during CPAP treatment (control group) and patients shifted to nasal mask due to persistent of obstructive events (AHI\>5) during the initial treatment with oronasal mask.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Carnevale syndrome

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Francesco Tavalazzi Principal Investigator

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)