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

NCT05272761 | Unknown

• 1 other identifier: 4901/19/120
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

OSA; Apnea+Hypopnea

Keywords

Breathing route; OSA; CPAP; Oronasal mask; Apnea hypopnea index; Air leak; Sleep efficiency

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Influence of position

  2 nights

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis moderate or severe OSA in treatment with CPAP in an Oronasal Mask

You may qualify if:

• Diagnosis of moderate or severe OSA in treatment with CPAP in an oronasal mask
• Years to 85 Years (Adult, Older Adult) (Adult, Older Adult)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Fundação Zerbini - Instituto do Coração (InCor)

São Paulo, São Paulo, 054039000, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 22855472 BACKGROUND

• Andrade 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.

  PMID: 27132703 BACKGROUND

• 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.

  PMID: 31238041 BACKGROUND

• 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.

  PMID: 33000960 BACKGROUND

• 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.

  PMID: 29273515 BACKGROUND

• Xavier 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.

  PMID: 39454998 DERIVED

Study Officials

• Geraldo Lorenzi-Filho, PHD

  Hospital das Clínicas HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geraldo Lorenzi-Filho

CONTACT

55112661-5486; geraldo.lorenzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: March 9, 2022
• Study Start: January 10, 2021
• Primary Completion: July 1, 2022
• Study Completion: February 18, 2024
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

BR (1)