Obstructive Sleep ApneaRESTECHNCT05110352
Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
A study testing Polysomnography, Pharyngeal ph-metry Restech and Peptest in people with Obstructive Sleep Apnea and Reflux, Laryngopharyngeal, run by Elsan at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Reflux, Laryngopharyngeal
- What is being tested?
- Polysomnography, Pharyngeal ph-metry Restech and Peptest
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2021to 23 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Epidemiological Study to Determine the 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.
- Conditions
- Obstructive Sleep Apnea, Reflux, Laryngopharyngeal
- Being tested
- Polysomnography, Pharyngeal ph-metry Restech, Peptest, Questionnaire RSS-12, Reflux Sign Assessment
- Medical subject headings
- Sleep Apnea, Obstructive, Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
A polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI).
Pharyngeal ph-metry RestechDiagnostic test
Pharyngeal ph-metry Restech over 24 hours (night and day)
PeptestProcedure or surgery
Saliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome
Questionnaire RSS-12Behavioural
Questionnaire with 12 items about quality of life. Score between 0 and 5.
Reflux Sign AssessmentProcedure or surgery
RSA score about anatomy and morphology of the mouth
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea Syndrome patients with polysomnography planned | Experimental | Apnea-Hypopnea Index (AHI) > 15 Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Pharyngeal ph-metry Restech; Procedure: Peptest; Behavioral: Questionnaire RSS-12; Procedure: Reflux Sign Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
RSS-12 score
Positive (>11)
Measured: 3 months
RSA score
Positive if > 14
Measured: 3 months
Peptest
Positive if > 75 ng / mL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Mar 2021
- Primary completion24 Jan 2022
- Study completion23 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110352
- Sponsor's protocol ID
- 2020-A02789-30
- Acronym
- RESTECH
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05110352
- Acronym / sponsor ID
- RESTECH / 2020-A02789-30
- Conditions
- Obstructive Sleep Apnea, Reflux, Laryngopharyngeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea Syndrome patients with polysomnography planned | Experimental | Diagnostic Test: Polysomnography, Diagnostic Test: Pharyngeal ph-metry Restech, Procedure: Peptest, Behavioral: Questionnaire RSS-12, Procedure: Reflux Sign AssessmentApnea-Hypopnea Index (AHI) > 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyA polysmnography is planned for every patients in order to evaluate the Apnea-Hypopnea Index (AHI). | Diagnostic test | Obstructive Sleep Apnea Syndrome patients with polysomnography planned |
| Pharyngeal ph-metry RestechPharyngeal ph-metry Restech over 24 hours (night and day) | Diagnostic test | Obstructive Sleep Apnea Syndrome patients with polysomnography planned |
| PeptestSaliva sample to look for an association between pharyngolaryngeal reflux and obstructive sleep apnea syndrome | Procedure or surgery | Obstructive Sleep Apnea Syndrome patients with polysomnography planned |
| Questionnaire RSS-12Questionnaire with 12 items about quality of life. Score between 0 and 5. | Behavioural | Obstructive Sleep Apnea Syndrome patients with polysomnography planned |
| Reflux Sign AssessmentRSA score about anatomy and morphology of the mouth | Procedure or surgery | Obstructive Sleep Apnea Syndrome patients with polysomnography planned |
Primary outcome
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
3 secondary outcomes
RSS-12 score
Time frame: 3 months
RSA score
Time frame: 3 months
Peptest
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography, Pharyngeal ph-metry Restech and Peptest in people with Obstructive Sleep Apnea and Reflux, Laryngopharyngeal, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Obstructive Sleep Apnea Syndrome diagnosed with pharyngolaryngeal reflux. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.