Impact of Breathing Route on CPAP Effectiveness to Treat Obstructive Sleep Apnea

OSA Clinical Trial

Official title:

Impact of Breathing Route on the Effectiveness of Treatment of Obstructive Sleep Apnea With CPAP and Oronasal Mask

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272761
• Other study ID #: 4901/19/120
• Status: Recruiting
• Start date: January 10, 2021
• Est. completion date: February 18, 2024

Study information

• Verified date: April 2022
• Source: University of Sao Paulo General Hospital
• Contact: Geraldo Lorenzi-Filho
• Phone: 55112661-5486
• Email: geraldo.lorenzi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 18, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• OSA
• Respiratory Aspiration
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Brazil	Fundação Zerbini - Instituto do Coração (InCor)	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Andrade RG, Madeiro F, Piccin VS, Moriya HT, Schorr F, Sardinha PS, Gregório 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. — View Citation

Andrade 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. — View Citation

Genta 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. — View Citation

Madeiro 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. — View Citation

Schorr F, Genta PR, Gregório 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 nights
Primary	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)	2 nights
Secondary	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.	2 nights