NCT05110352

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Reflux, Laryngopharyngeal

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Polysomnography	A polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI).
DIAGNOSTIC_TEST	Pharyngeal ph-metry Restech	Pharyngeal ph-metry Restech over 24 hours (night and day)
PROCEDURE	Peptest	Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome
BEHAVIORAL	Questionnaire RSS-12	Questionnaire with 12 items about quality of life. Score between 0 and 5.
PROCEDURE	Reflux Sign Assessment	RSA score about anatomy and morphology of the mouth

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-01-24
• Completion: 2022-04-23
• First posted: 2021-11-05
• Last updated: 2022-10-26

Locations

1 site across 1 country: France