Effect of CPAP Therapy on LPR Among Patients With OSAS

NCT ID: NCT03455803

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-31

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laryngopharyngeal Reflux Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CPAP

Continuous positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aya Abouelela

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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332890

Identifier Type: -

Identifier Source: org_study_id

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