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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Reflux, Laryngopharyngeal
• Interventions: Diagnostic Test: Polysomnography; Diagnostic Test: Pharyngeal ph-metry Restech; Procedure: Peptest; Behavioral: Questionnaire RSS-12; Procedure: Reflux Sign Assessment

• Registration Number: NCT05110352
• Lead Sponsor: Elsan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Primary Completion: 2022-01-24
• Study Completion: 2022-04-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obstructive Sleep Apnea Syndrome patients with polysomnography planned	Polysomnography	Apnea-Hypopnea Index (AHI) \> 15
Obstructive Sleep Apnea Syndrome patients with polysomnography planned	Pharyngeal ph-metry Restech	Apnea-Hypopnea Index (AHI) \> 15
Obstructive Sleep Apnea Syndrome patients with polysomnography planned	Reflux Sign Assessment	Apnea-Hypopnea Index (AHI) \> 15
Obstructive Sleep Apnea Syndrome patients with polysomnography planned	Questionnaire RSS-12	Apnea-Hypopnea Index (AHI) \> 15
Obstructive Sleep Apnea Syndrome patients with polysomnography planned	Peptest	Apnea-Hypopnea Index (AHI) \> 15

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux.	3 months	the diagnosis of OSA is posed by the PSG as soon as the AHI is ≥ 15 / h

Secondary Outcome Measures

Name	Time	Method
Peptest	3 months	Positive if \> 75 ng / mL
RSS-12 score	3 months	Positive (\>11)
RSA score	3 months	Positive if \> 14

Trial Locations

Locations (1)

Centre du Sommeil de la Polyclinique de Poitiers; 🇫🇷 Potiers, France