Status unknownNCT03455803Updated Mar 7, 2018

Effect of CPAP Therapy on LPR Among Patients With OSAS

An observational study in Laryngopharyngeal Reflux and Obstructive Sleep Apnea, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 30
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Laryngopharyngeal Reflux
Obstructive Sleep Apnea

Browse trials for

In context

Laryngopharyngeal Reflux

56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.

Browse Laryngopharyngeal Reflux studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 30 participants (estimated)
Patient registry: No

Interventions

DeviceCPAP
Continuous positive airway pressure

What researchers measure

Primary outcomes

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
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
Time frame: Change from the baseline RFS at 3 months of regular humidified CPAP application

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2018; primary completion for May 2020, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 21, 2018
First posted: Mar 7, 2018
StartEst.: May 2018
Primary completionEst.: May 2020
CompletionEst.: Sep 2021
Last update: Mar 7, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03455803
Lead sponsor: Assiut University
Responsible party: Aya Abouelela (Assistant Lecturer, Assiut University) — Principal investigator
First posted: Mar 7, 2018
Start date: May 2018 (estimated)
Primary completion: May 2020 (estimated)
Completion: Sep 2021 (estimated)
Last update: Mar 7, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Laryngopharyngeal Reflux →

Other studies from this sponsor

Assiut University →

Start the discussion