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Completed

NCT Number: NCT05110352

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre du Sommeil de la Polyclinique de Poitiers

Potiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Diagnostic Test

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

Pharyngeal ph-metry Restech

Diagnostic Test

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

Peptest

Procedure

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

Questionnaire RSS-12

Behavioral

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

Reflux Sign Assessment

Procedure

RSA score about anatomy and morphology of the mouth

Primary outcomes

  1. 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

Secondary outcomes

  1. RSS-12 score

    Time frame: 3 months

    Positive (>11)

  2. RSA score

    Time frame: 3 months

    Positive if > 14

  3. Peptest

    Time frame: 3 months

    Positive if > 75 ng / mL

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: RESTECH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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