Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
NCT05110352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2022-10-26
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
- 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
Sponsors & Collaborators
-
Elsan
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-24
- Primary Completion
- 2022-01-24
- Completion
- 2022-04-23
Countries
- France
Study Locations
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