NCT03455803

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

February 21, 2018

Last Update Submit

March 5, 2018

Conditions

Laryngopharyngeal RefluxObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

CPAPDEVICE

Continuous positive airway pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Laryngopharyngeal RefluxSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 7, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

September 1, 2021

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share