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

October 25, 2022 updated by: Elsan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Potiers, France
        • Centre du Sommeil de la Polyclinique de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional 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
Apnea-Hypopnea Index (AHI) > 15
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux.
Time Frame: 3 months
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
Time Frame: 3 months
Positive (>11)
3 months
RSA score
Time Frame: 3 months
Positive if > 14
3 months
Peptest
Time Frame: 3 months
Positive if > 75 ng / mL
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

January 24, 2022

Study Completion (Actual)

April 23, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02789-30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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