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

E

Elsan

Status

Completed

Conditions

Reflux, Laryngopharyngeal
Obstructive Sleep Apnea

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05110352
2020-A02789-30

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Obstructive Sleep Apnea Syndrome patients with polysomnography planned
Experimental group
Description:
Apnea-Hypopnea Index (AHI) \> 15
Treatment:
Behavioral: Questionnaire RSS-12
Diagnostic Test: Pharyngeal ph-metry Restech
Procedure: Peptest
Diagnostic Test: Polysomnography
Procedure: Reflux Sign Assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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