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

Primary Purpose

Obstructive Sleep Apnea, Reflux, Laryngopharyngeal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography
Pharyngeal ph-metry Restech
Peptest
Questionnaire RSS-12
Reflux Sign Assessment
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre du Sommeil de la Polyclinique de Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obstructive Sleep Apnea Syndrome patients with polysomnography planned

Arm Description

Apnea-Hypopnea Index (AHI) > 15

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

RSS-12 score
Positive (>11)
RSA score
Positive if > 14
Peptest
Positive if > 75 ng / mL

Full Information

First Posted
October 21, 2021
Last Updated
October 25, 2022
Sponsor
Elsan
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1. Study Identification

Unique Protocol Identification Number
NCT05110352
Brief Title
Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
Acronym
RESTECH
Official Title
Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
April 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Reflux, Laryngopharyngeal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obstructive Sleep Apnea Syndrome patients with polysomnography planned
Arm Type
Experimental
Arm Description
Apnea-Hypopnea Index (AHI) > 15
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Intervention Description
A polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI).
Intervention Type
Diagnostic Test
Intervention Name(s)
Pharyngeal ph-metry Restech
Intervention Description
Pharyngeal ph-metry Restech over 24 hours (night and day)
Intervention Type
Procedure
Intervention Name(s)
Peptest
Intervention Description
Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire RSS-12
Intervention Description
Questionnaire with 12 items about quality of life. Score between 0 and 5.
Intervention Type
Procedure
Intervention Name(s)
Reflux Sign Assessment
Intervention Description
RSA score about anatomy and morphology of the mouth
Primary Outcome Measure Information:
Title
Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux.
Description
the diagnosis of OSA is posed by the PSG as soon as the AHI is ≥ 15 / h
Time Frame
3 months
Secondary Outcome Measure Information:
Title
RSS-12 score
Description
Positive (>11)
Time Frame
3 months
Title
RSA score
Description
Positive if > 14
Time Frame
3 months
Title
Peptest
Description
Positive if > 75 ng / mL
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre du Sommeil de la Polyclinique de Poitiers
City
Potiers
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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