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Effect of CPAP Therapy on LPR Among Patients With OSAS

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ClinicalTrials.gov Identifier: NCT03455803
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aya Abouelela, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Laryngopharyngeal Reflux Obstructive Sleep Apnea Device: CPAP

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Sleep Apnea


Intervention Details:
  • Device: CPAP
    Continuous positive airway pressure


Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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.

Responsible Party: Aya Abouelela, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03455803     History of Changes
Other Study ID Numbers: 332890
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Laryngopharyngeal Reflux
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases