Effect of CPAP Therapy on LPR Among Patients With OSAS

March 5, 2018 updated by: Aya Abouelela, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from the baseline RSI at 3 months of regular humidified CPAP application
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
Change from the baseline RFS at 3 months of regular humidified CPAP application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 332890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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