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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05110352
Acronym
RESTECH
Enrollment
37
Registered
2021-11-05
Start date
2021-03-24
Completion date
2022-04-23
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Reflux, Laryngopharyngeal

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.

Interventions

DIAGNOSTIC_TESTPolysomnography

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

DIAGNOSTIC_TESTPharyngeal ph-metry Restech

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

PROCEDUREPeptest

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

BEHAVIORALQuestionnaire RSS-12

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

PROCEDUREReflux Sign Assessment

RSA score about anatomy and morphology of the mouth

Sponsors

Elsan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux.3 monthsthe diagnosis of OSA is posed by the PSG as soon as the AHI is ≥ 15 / h

Secondary

MeasureTime frameDescription
RSS-12 score3 monthsPositive (\>11)
RSA score3 monthsPositive if \> 14
Peptest3 monthsPositive if \> 75 ng / mL

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026