OSANCT05272761
Impact of Breathing Route on CPAP Effectiveness to Treat Obstructive Sleep Apnea
An observational study of OSA and Apnea+Hypopnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using CPAP with oronasal mask on CPAP level, residual AHI, and peak flow. In addition, the impact of position (lateral vs supine position) will be evaluated during PSG. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- OSA, Apnea+Hypopnea
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2021to 18 Feb 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis moderate or severe OSA in treatment with CPAP in an Oronasal Mask
Who may be able to join
- Diagnosis of moderate or severe OSA in treatment with CPAP in an oronasal mask
- 18 Years to 85 Years (Adult, Older Adult) (Adult, Older Adult)
Who cannot join
- Other sleep disturbance (insomnia, parasomnias, narcolepsy, central sleep apnea).
- Uncontrolled clinical disease (diabetes, kidney or heart failure, recent stroke or coronary failure and recent postoperative period, oxygen dependent COPD).
- Patients adapted to other types of masks.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fundação Zerbini - Instituto do Coração (InCor)
São Paulo, São Paulo, 054039000
Geraldo Lorenzi-Filho, PhD, 55 11 2661-5486, geraldo.lorenzi@gmail.com
Jeane Andrade, PT, 55 11 2661-5486, jeaneandrade.fisio@gmail.com
About this study
Official title: Impact of Breathing Route on the Effectiveness of Treatment of Obstructive Sleep Apnea With CPAP and Oronasal Mask
To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using CPAP with oronasal mask on CPAP level, residual AHI, and peak flow. In addition, the impact of position (lateral vs supine position) will be evaluated during PSG.
Read the detailed description
Application of Continuous Positive Upper Airway Pressure (CPAP) during sleep using nasal mask is the gold standard treatment for Obstructive Sleep Apnea (OSA). In clinical practice, many patients with OSA are considered mouth breathers and use an oronasal mask. However, CPAP delivered by the mouth violates the principal of CPAP use to treat OSA. This study is part of a line of research over the last decade that started with the observation of a patient that CPAP delivered by an oronasal mask failed to splint the airway open and to abolish OSA . We showed subsequently in acute studies during induced-sleep that oronasal CPAP only works when the patient breathes predominantly through the nose. These observations prompted our group to lead one workshop on the importance of mask selection. One meta-analysis from our group confirmed that oronasal CPAP is associated with a higher CPAP level, higher residual AHI, and poorer adherence than nasal CPAP. Despite all this evidence the investigators intrigued by the clinical observation that oronasal masks remains common and several patients on clinical practice are well adapted to oronasal CPAP. In this study, 20 patients with OSA well adapted to the oronasal mask will be recruited. The patients will be invited to be submitted to 2 independent CPAP titration sleep studies using a customized oronasal mask with a sealed and independent nasal and oral compartments coupled to 2 pneumotachographs. One CPAP titration will be with the nasal and oral routes open and one CPAP titration with only the oral compartment opened. Our hypotheses are that obstruction of nasal compartment during CPAP titration causuing mouth breathing will result in higher CPAP and higher residual apnea-hypopnea index. Patients with OSA under treatment with oronasal CPAP will undergo CPAP titration polysomnography on 2 different nights. In one night the patient will sleep with the oral and nasal compartments opened and in another night interposed by at least seven days, the patient with sleep with only the oral compartment opened. The order of the 2 sleep studies will be randomized. Thus, researchers will assess the impact of the airway (oral vs oronasal) on titrated CPAP level, residual AHI, and sleep efficiency in supine and lateral recumbency. In addition, the preferred airway during the oronasal mask will be analyzed. At the end of the study a nasal mask will be offered to all patients.
- Conditions
- OSA, Apnea+Hypopnea
- Keywords
- Breathing route, OSA, CPAP, Oronasal mask, Apnea hypopnea index, Air leak, Sleep efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oronasal Route | Patients will sleep in the sleep lab for CPAP titration wearing a custom oronasal mask with 2 open oral and nasal compartments. The titration was split between the first half of the night and the second half. The titration will be started with the patient remaining for 90 minutes with the pressure he uses at home (supine position and in lateral decubitus), after a period of 90 minutes the patient will be titrated in order to abolish respiratory events in both positions of the body. | |
| Oral Route | Group/Cohort Interventions Oronasal Route Patients will sleep in the sleep lab for CPAP titration using a custom 2-compartment oronasal mask. In this titration, the nasal compartment will be closed and the patient will be titrated only through the oral route. The titration split between the first half of the night and the second half. The titration will be started with the patient staying for 90 minutes with the pressure used at home (during the supine position and lateral position), after the 90 minute period the patient will be titrated in order to abolish respiratory events in both positions of the body. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of breathing route on residual AHI
To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using oronasal mask on residual AHI ( Apnea-hypopnea Index).
Measured: 2 nights
Impact of breathing route on the CPAP
To determine the impact of the CPAP route (oronasal vs oral) in patients during titration of the CPAP route (oronasal vs oral)
Measured: 2 nights
Secondary outcomes (1)
Influence of position
To assess the influence of body position on the CPAP pressure used at home by the patient in the oral and oronasal route.
Measured: 2 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start10 Jan 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion18 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
- Investigators
- Geraldo Lorenzi-Filho, PHD, Principal investigator, Hospital das Clínicas HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272761
- Sponsor's protocol ID
- 4901/19/120
- Status last verified
- Apr 2022
- First submitted
- 28 Dec 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schorr F, Genta PR, Gregorio MG, Danzi-Soares NJ, Lorenzi-Filho G. Continuous positive airway pressure delivered by oronasal mask may not be effective for obstructive sleep apnoea. Eur Respir J. 2012 Aug;40(2):503-5. doi: 10.1183/09031936.00145111. No abstract available.
PubMed 22855472Andrade RG, Madeiro F, Piccin VS, Moriya HT, Schorr F, Sardinha PS, Gregorio MG, Genta PR, Lorenzi-Filho G. Impact of Acute Changes in CPAP Flow Route in Sleep Apnea Treatment. Chest. 2016 Dec;150(6):1194-1201. doi: 10.1016/j.chest.2016.04.017. Epub 2016 Apr 29.
PubMed 27132703Madeiro F, Andrade RGS, Piccin VS, Pinheiro GDL, Moriya HT, Genta PR, Lorenzi-Filho G. Transmission of Oral Pressure Compromises Oronasal CPAP Efficacy in the Treatment of OSA. Chest. 2019 Dec;156(6):1187-1194. doi: 10.1016/j.chest.2019.05.024. Epub 2019 Jun 22.
PubMed 31238041Genta PR, Kaminska M, Edwards BA, Ebben MR, Krieger AC, Tamisier R, Ye L, Weaver TE, Vanderveken OM, Lorenzi-Filho G, DeYoung P, Hevener W, Strollo P. The Importance of Mask Selection on Continuous Positive Airway Pressure Outcomes for Obstructive Sleep Apnea. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2020 Oct;17(10):1177-1185. doi: 10.1513/AnnalsATS.202007-864ST.
PubMed 33000960Andrade RGS, Viana FM, Nascimento JA, Drager LF, Moffa A, Brunoni AR, Genta PR, Lorenzi-Filho G. Nasal vs Oronasal CPAP for OSA Treatment: A Meta-Analysis. Chest. 2018 Mar;153(3):665-674. doi: 10.1016/j.chest.2017.10.044. Epub 2017 Dec 19.
PubMed 29273515Xavier JLA, Fernandes MD, Andrade RGS, Genta PR, Lorenzi-Filho G. Impact of Exclusive Mouth Route and Lateral Position on the Efficacy of Oronasal CPAP to Treat OSA in Patients With OSA Adapted to Oronasal Mask. Chest. 2025 Feb;167(2):611-618. doi: 10.1016/j.chest.2024.10.023. Epub 2024 Oct 24.
PubMed 39454998
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breathing Route on the Effectiveness of Treatment of Obstructive Sleep Apnea With CPAP and Oronasal Mask
- ClinicalTrials.gov ID
- NCT05272761
- Acronym / sponsor ID
- 4901/19/120
- Conditions
- OSA, Apnea+Hypopnea
- Keywords
- Breathing route, OSA, CPAP, Oronasal mask, Apnea hypopnea index, Air leak, Sleep efficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 18 Feb 2024 (estimated)
- First posted
- 9 Mar 2022 (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.
To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using CPAP with oronasal mask on CPAP level, residual AHI, and peak flow. In addition, the impact of position (lateral vs supine position) will be evaluated during PSG.
Detailed description
Application of Continuous Positive Upper Airway Pressure (CPAP) during sleep using nasal mask is the gold standard treatment for Obstructive Sleep Apnea (OSA). In clinical practice, many patients with OSA are considered mouth breathers and use an oronasal mask. However, CPAP delivered by the mouth violates the principal of CPAP use to treat OSA. This study is part of a line of research over the last decade that started with the observation of a patient that CPAP delivered by an oronasal mask failed to splint the airway open and to abolish OSA . We showed subsequently in acute studies during induced-sleep that oronasal CPAP only works when the patient breathes predominantly through the nose. These observations prompted our group to lead one workshop on the importance of mask selection. One meta-analysis from our group confirmed that oronasal CPAP is associated with a higher CPAP level, higher residual AHI, and poorer adherence than nasal CPAP. Despite all this evidence the investigators intrigued by the clinical observation that oronasal masks remains common and several patients on clinical practice are well adapted to oronasal CPAP. In this study, 20 patients with OSA well adapted to the oronasal mask will be recruited. The patients will be invited to be submitted to 2 independent CPAP titration sleep studies using a customized oronasal mask with a sealed and independent nasal and oral compartments coupled to 2 pneumotachographs. One CPAP titration will be with the nasal and oral routes open and one CPAP titration with only the oral compartment opened. Our hypotheses are that obstruction of nasal compartment during CPAP titration causuing mouth breathing will result in higher CPAP and higher residual apnea-hypopnea index. Patients with OSA under treatment with oronasal CPAP will undergo CPAP titration polysomnography on 2 different nights. In one night the patient will sleep with the oral and nasal compartments opened and in another night interposed by at least seven days, the patient with sleep with only the oral compartment opened. The order of the 2 sleep studies will be randomized. Thus, researchers will assess the impact of the airway (oral vs oronasal) on titrated CPAP level, residual AHI, and sleep efficiency in supine and lateral recumbency. In addition, the preferred airway during the oronasal mask will be analyzed. At the end of the study a nasal mask will be offered to all patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oronasal Route | – | –Patients will sleep in the sleep lab for CPAP titration wearing a custom oronasal mask with 2 open oral and nasal compartments. The titration was split between the first half of the night and the second half. The titration will be started with the patient remaining for 90 minutes with the pressure he uses at home (supine position and in lateral decubitus), after a period of 90 minutes the patient will be titrated in order to abolish respiratory events in both positions of the body. |
| Oral Route | – | –Group/Cohort Interventions Oronasal Route Patients will sleep in the sleep lab for CPAP titration using a custom 2-compartment oronasal mask. In this titration, the nasal compartment will be closed and the patient will be titrated only through the oral route. The titration split between the first half of the night and the second half. The titration will be started with the patient staying for 90 minutes with the pressure used at home (during the supine position and lateral position), after the 90 minute period the patient will be titrated in order to abolish respiratory events in both positions of the body. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis moderate or severe OSA in treatment with CPAP in an Oronasal Mask
Key inclusion criteria (2 listed)
- Diagnosis of moderate or severe OSA in treatment with CPAP in an oronasal mask
- 18 Years to 85 Years (Adult, Older Adult) (Adult, Older Adult)
Key exclusion criteria (3 listed)
- Other sleep disturbance (insomnia, parasomnias, narcolepsy, central sleep apnea).
- Uncontrolled clinical disease (diabetes, kidney or heart failure, recent stroke or coronary failure and recent postoperative period, oxygen dependent COPD).
- Patients adapted to other types of masks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of breathing route on residual AHI
Time frame: 2 nights
To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using oronasal mask on residual AHI ( Apnea-hypopnea Index).
Impact of breathing route on the CPAP
Time frame: 2 nights
To determine the impact of the CPAP route (oronasal vs oral) in patients during titration of the CPAP route (oronasal vs oral)
1 secondary outcome
Influence of position
Time frame: 2 nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Background: PubMed 22855472Schorr F, Genta PR, Gregorio MG, Danzi-Soares NJ, Lorenzi-Filho G. Continuous positive airway pressure delivered by oronasal mask may not be effective for obstructive sleep apnoea. Eur Respir J. 2012 Aug;40(2):503-5. doi: 10.1183/09031936.00145111. No abstract available.
- Background: PubMed 27132703Andrade RG, Madeiro F, Piccin VS, Moriya HT, Schorr F, Sardinha PS, Gregorio MG, Genta PR, Lorenzi-Filho G. Impact of Acute Changes in CPAP Flow Route in Sleep Apnea Treatment. Chest. 2016 Dec;150(6):1194-1201. doi: 10.1016/j.chest.2016.04.017. Epub 2016 Apr 29.
- Background: PubMed 31238041Madeiro F, Andrade RGS, Piccin VS, Pinheiro GDL, Moriya HT, Genta PR, Lorenzi-Filho G. Transmission of Oral Pressure Compromises Oronasal CPAP Efficacy in the Treatment of OSA. Chest. 2019 Dec;156(6):1187-1194. doi: 10.1016/j.chest.2019.05.024. Epub 2019 Jun 22.
- Background: PubMed 33000960Genta PR, Kaminska M, Edwards BA, Ebben MR, Krieger AC, Tamisier R, Ye L, Weaver TE, Vanderveken OM, Lorenzi-Filho G, DeYoung P, Hevener W, Strollo P. The Importance of Mask Selection on Continuous Positive Airway Pressure Outcomes for Obstructive Sleep Apnea. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2020 Oct;17(10):1177-1185. doi: 10.1513/AnnalsATS.202007-864ST.
- Background: PubMed 29273515Andrade RGS, Viana FM, Nascimento JA, Drager LF, Moffa A, Brunoni AR, Genta PR, Lorenzi-Filho G. Nasal vs Oronasal CPAP for OSA Treatment: A Meta-Analysis. Chest. 2018 Mar;153(3):665-674. doi: 10.1016/j.chest.2017.10.044. Epub 2017 Dec 19.
- Derived from this study: PubMed 39454998Xavier JLA, Fernandes MD, Andrade RGS, Genta PR, Lorenzi-Filho G. Impact of Exclusive Mouth Route and Lateral Position on the Efficacy of Oronasal CPAP to Treat OSA in Patients With OSA Adapted to Oronasal Mask. Chest. 2025 Feb;167(2):611-618. doi: 10.1016/j.chest.2024.10.023. Epub 2024 Oct 24.
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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.
Geraldo Lorenzi-Filho, PHD principal investigator
Hospital das Clínicas HCFMUSP
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 and Apnea+Hypopnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 May 2022. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geraldo Lorenzi-Filho (55112661-5486, geraldo.lorenzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of breathing route on residual AHI (time frame: 2 nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272761, which also lists 6 linked publications.
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 3 May 2022.