Effect of CPAP Therapy on LPR Among Patients With OSAS

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03455803
• Other study ID #: 332890
• Status: Not yet recruiting
• Phase: N/A
• First received: February 21, 2018
• Last updated: March 5, 2018
• Start date: May 2018
• Est. completion date: September 2021

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Continuous positive airway pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from the baseline RSI at 3 months of regular humidified CPAP application
Primary	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	Change from the baseline RFS at 3 months of regular humidified CPAP application