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

NCT05110352 | Completed

• 1 other identifier: 2020-A02789-30
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Reflux, Laryngopharyngeal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• RSS-12 score

  3 months

• RSA score

  3 months

• Peptest

  3 months

Study Arms (1)

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

EXPERIMENTAL

Apnea-Hypopnea Index (AHI) \> 15

Diagnostic Test: Polysomnography; Diagnostic Test: Pharyngeal ph-metry Restech; Procedure: Peptest; Behavioral: Questionnaire RSS-12; Procedure: Reflux Sign Assessment

Interventions

Polysomnography DIAGNOSTIC_TEST

A polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI).

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Pharyngeal ph-metry Restech DIAGNOSTIC_TEST

Pharyngeal ph-metry Restech over 24 hours (night and day)

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Peptest PROCEDURE

Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Questionnaire RSS-12 BEHAVIORAL

Questionnaire with 12 items about quality of life. Score between 0 and 5.

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Reflux Sign Assessment PROCEDURE

RSA score about anatomy and morphology of the mouth

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Centre du Sommeil de la Polyclinique de Poitiers

Potiers, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Laryngopharyngeal Reflux

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 5, 2021
• Study Start: March 24, 2021
• Primary Completion: January 24, 2022
• Study Completion: April 23, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

FR (1)