UnknownNot Applicable

Effect of CPAP Therapy on LPR Among Patients With OSAS

30 participantsStarted 2018-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reflux symptom index (RSI) change

Timeframe: Change from the baseline RSI at 3 months of regular humidified CPAP application

Reflux finding score (RFS) change

Timeframe: Change from the baseline RFS at 3 months of regular humidified CPAP application

Trial details

NCT IDNCT03455803

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-05

View on ClinicalTrials.gov More Laryngopharyngeal Reflux trials