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

Study Overview
=================
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.

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.

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

Conditions
-----------------
OSA, Apnea+Hypopnea

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oronasal Route<br>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<br>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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breathing route, OSA, CPAP, Oronasal mask, Apnea hypopnea index, Air leak, Sleep efficiency