Laryngopharyngeal RefluxNCT03455803
Effect of CPAP Therapy on LPR Among Patients With OSAS
An observational study of Laryngopharyngeal Reflux and Obstructive Sleep Apnea, run by Assiut University.
Trial summary
This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngopharyngeal Reflux, Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Sep 2021
- Phase
- Observational
- 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
Study population: Primary care clinic
Who may be able to join
- Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study.
- To be eligible as LPR patients in our study, patients must have presented a RSI score > 13 and a RFS score > 7. These thresholds were highly correlated with pathological pH monitoring (pH < 4)
Who cannot join
- Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant.
- Antireflux therapy during the period of the study.
About this study
Official title: Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea
This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them.
- Conditions
- Laryngopharyngeal Reflux, Obstructive Sleep Apnea
- Being tested
- CPAP
- Medical subject headings
- Laryngopharyngeal Reflux, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Continuous positive airway pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux symptom index (RSI) change
Assessment of the changes in the reflux symptom index (RSI) among patients with obstructive sleep apnea according to the determined time frame
Measured: Change from the baseline RSI at 3 months of regular humidified CPAP application
Reflux finding score (RFS) change
Assessment of the changes in the reflux finding score (RFS) among patients with obstructive sleep apnea according to the determined time frame
Measured: Change from the baseline RFS at 3 months of regular humidified CPAP application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abouelela, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455803
- Sponsor's protocol ID
- 332890
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03455803
- Acronym / sponsor ID
- 332890
- Conditions
- Laryngopharyngeal Reflux, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 7 Mar 2018 (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.
This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study.
- To be eligible as LPR patients in our study, patients must have presented a RSI score > 13 and a RFS score > 7. These thresholds were highly correlated with pathological pH monitoring (pH < 4)
Key exclusion criteria (2 listed)
- Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant.
- Antireflux therapy during the period of the study.
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 |
|---|---|---|
| CPAPContinuous positive airway pressure | Device | – |
Primary outcome
Reflux symptom index (RSI) change
Time frame: Change from the baseline RSI at 3 months of regular humidified CPAP application
Assessment of the changes in the reflux symptom index (RSI) among patients with obstructive sleep apnea according to the determined time frame
Reflux finding score (RFS) change
Time frame: Change from the baseline RFS at 3 months of regular humidified CPAP application
Assessment of the changes in the reflux finding score (RFS) among patients with obstructive sleep apnea according to the determined time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngopharyngeal Reflux and Obstructive Sleep Apnea, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Reflux symptom index (RSI) change (time frame: Change from the baseline RSI at 3 months of regular humidified CPAP application). The study lists 2 primary outcomes in all. 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 7 Mar 2018.