Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
NCT ID: NCT05110352
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
37 participants
INTERVENTIONAL
2021-03-24
2022-04-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of CPAP Therapy on LPR Among Patients With OSAS
NCT03455803
Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
NCT05808868
Enhanced Respiratory Polygraphy in Suspected OSA
NCT05949853
Cough Reflex and Obstructive Sleep Apnea Syndrome
NCT00317083
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
NCT00194376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Obstructive Sleep Apnea Syndrome patients with polysomnography planned
Apnea-Hypopnea Index (AHI) \> 15
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)
Peptest
Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome
Questionnaire RSS-12
Questionnaire with 12 items about quality of life. Score between 0 and 5.
Reflux Sign Assessment
RSA score about anatomy and morphology of the mouth
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Peptest
Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome
Questionnaire RSS-12
Questionnaire with 12 items about quality of life. Score between 0 and 5.
Reflux Sign Assessment
RSA score about anatomy and morphology of the mouth
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elsan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre du Sommeil de la Polyclinique de Poitiers
Potiers, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A02789-30
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.