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

Obstructive Sleep Apnea Clinical Trial

— RESTECH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110352
• Other study ID #: 2020-A02789-30
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: April 23, 2022

Study information

• Verified date: October 2022
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 23, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Centre du Sommeil de la Polyclinique de Poitiers	Potiers

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	RSS-12 score	Positive (>11)	3 months
Secondary	RSA score	Positive if > 14	3 months
Secondary	Peptest	Positive if > 75 ng / mL	3 months