Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

Study Overview
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Brief Summary
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CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

Detailed Description
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Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.

Official Title
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Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal nasal breathing dentition allowing for use of an oral appliance absence of mandibular joint pathology Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface Patients using CPAP less than 3 hours/day as prescribed following CPAP titration Exclusion Criteria: Clinical instability smoking cessation current weight loss strategy Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy) severe cardio-metabolic co-morbidity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oro-nasal mask<br>Oro-nasal mask during 1 month of auto CPAP | Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy<br> <br> |
| Experimental: Nasal mask and oral appliance<br>Nasal mask and oral appliance during 1 month of auto CPAP | Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP compliance | CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition. | After 4 weeks of CPAP trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diurnal somnolence | Epworth Sleepiness Score | After 4 weeks of CPAP trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP compliance, leaks, Respiratory disturbances index, quality of life