Osa SyndromeNCT04681196
Nasal Versus Oronasal Mask in Continuous Positive Airway Pressure (CPAP) Treatment of Patients Affected by Obstructive Sleep Apnea Syndrome (OSAS).
An observational study of Osa Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osa Syndrome
- What is being tested?
- patients shifted to nasal mask after persistent OSA with oronasal mask
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- confirmed diagnosis of OSA and use of CPAP treatment
- age> or equal to 18 years old
- sign of informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Policlinico S. Orsola-Malpighi
Bologna, 40138
About this study
Official title: Evaluation of Different Effects of Nasal Versus Oronasal Mask in Continuous Positive Airway Pressure (CPAP) Treatment of Patients Affected by Obstructive Sleep Apnea Syndrome (OSAS).
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.
Read more
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.
Read the 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
- Being tested
- patients shifted to nasal mask after persistent OSA with oronasal mask
- Keywords
- OSAS, CPAP, nasal mask, oronasal mask
- Medical subject headings
- Carnevale syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients shifted to nasal mask after persistent OSA with oronasal maskOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osa SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Tavalazzi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681196
- Sponsor's protocol ID
- 195/2020/Oss/AOUBO
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Effects of Nasal Versus Oronasal Mask in Continuous Positive Airway Pressure (CPAP) Treatment of Patients Affected by Obstructive Sleep Apnea Syndrome (OSAS).
- ClinicalTrials.gov ID
- NCT04681196
- Acronym / sponsor ID
- 195/2020/Oss/AOUBO
- Conditions
- Osa Syndrome
- Keywords
- OSAS, CPAP, nasal mask, oronasal mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients affected by OSA treated with CPAP / paradox effect group | – | Other: patients shifted to nasal mask after persistent OSA with oronasal maskpatients 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 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- confirmed diagnosis of OSA and use of CPAP treatment
- age> or equal to 18 years old
- sign of informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients shifted to nasal mask after persistent OSA with oronasal maskIn 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 | Other | patients affected by OSA treated with CPAP / paradox effect group |
Primary outcome
differences in terms of age between groups
Time frame: Up to one month.
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
differences in terms of body mass index between groups
Time frame: Up to one month.
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.
differences in terms of basal value of apnea-hypopnea index (OSA severity) between groups
Time frame: Up to one month.
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.
differences in terms of basal value of minimum and mean nocturnal oxygen saturation between groups.
Time frame: Up to one month.
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).
differences in terms of basal value of time spent under SpO2<90% and under SpO2<80% between groups.
Time frame: Up to one month.
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.
differences in terms of oxygen desaturation index between groups.
Time frame: Up to one month.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osa Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in terms of age between groups (time frame: Up to one month.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.