Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

Study Overview
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Brief Summary
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The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome. It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.

Official Title
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Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea, Reflux, Laryngopharyngeal

Intervention / Treatment
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* Diagnostic Test: Polysomnography
* Diagnostic Test: Pharyngeal ph-metry Restech
* Procedure: Peptest
* Behavioral: Questionnaire RSS-12
* Procedure: Reflux Sign Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (> 18 ans) Polysomnography planned for OSA assessment RPL known or not, suspected or not Affiliation to a social security scheme or beneficiary of such a scheme Patient having signed the free and informed consent Exclusion Criteria: Minors Smoking, alcoholism, chronic or serious disabling pathology Medical history of upper aerodigestive tract cancer, radiotherapy Recent infection of upper aerodigestive tract, chronic rhinosinusitis Permanent nasal obstruction Active allergy Non-obstructive SAS (central) Patient under anti-secretory treatment (IPP) during the 8 days preceding the Restech associated with the PSG Refusal to participate in the study Protected patients: Adults under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant, breastfeeding or parturient Hospitalized without consent

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obstructive Sleep Apnea Syndrome patients with polysomnography planned<br>Apnea-Hypopnea Index (AHI) > 15 | Diagnostic Test: Polysomnography<br>* A polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI).<br>Diagnostic Test: Pharyngeal ph-metry Restech<br>* Pharyngeal ph-metry Restech over 24 hours (night and day)<br>Procedure: Peptest<br>* Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome<br>Behavioral: Questionnaire RSS-12<br>* Questionnaire with 12 items about quality of life. Score between 0 and 5.<br>Procedure: Reflux Sign Assessment<br>* RSA score about anatomy and morphology of the mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux. | the diagnosis of OSA is posed by the PSG as soon as the AHI is ≥ 15 / h | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSS-12 score | Positive (>11) | 3 months | 
| RSA score | Positive if > 14 | 3 months | 
| Peptest | Positive if > 75 ng / mL | 3 months |