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

April 26, 2022 updated by: Geraldo Lorenzi Filho, University of Sao Paulo General Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 054039000
        • Recruiting
        • Fundação Zerbini - Instituto do Coração (InCor)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 nights
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)
2 nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of position
Time Frame: 2 nights
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2021

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

February 18, 2024

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

March 8, 2022

First Posted (ACTUAL)

March 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4901/19/120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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