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Sleep apnea machine tested for IPF lung health – but study stopped early

NCT ID NCT05359965

Knowledge-focused Sponsor: University of Arizona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether using a CPAP machine at night could reduce abnormal acid reflux and lung inflammation in people with idiopathic pulmonary fibrosis (IPF) who also have sleep apnea. Only 7 people enrolled before the study was terminated early. The goal was to measure changes in certain lung inflammation markers and acid levels in the esophagus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Continuous Positive Airway Pressure (CPAP) device
What this could lead to
If it had succeeded, this could have pointed toward a way to manage reflux and lung inflammation in IPF patients with sleep apnea.
What could go wrong
The study was terminated early with only 7 participants, so results are very limited. It is too small and incomplete to draw any conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

7 people

The number who actually took part.

Started

Oct 2019

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * confirmed diagnosis of IPF based on the 2018 IPF guidelines * high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater * patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study * able to participated in 24hr pH monitoring * able to comply with CPAP treatment * able to provide written informed consent prior to any study procedures * willing to complete all study measurements and assessments in compliance with the protocol Exclusion Criteria: * interstitial lung disease caused by conditions other than IPF * severe concomitant illness limiting life expectancy (\< 1 year) * residual lung volume \> or equal to 120% of predicted * obstructive lung disease: FEV1/FVC ratio \< 0.70 * current drug or alcohol dependence * patients who are unable to tolerate nintedanib * patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement * patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered) * patients who have had prior nasal surgery or trauma that would make pH probe placement difficult * patients on anticoagulation (aspirin is not an exclusion)

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease idiopathic pulmonary fibrosis obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastro esophageal reflux Idiopathic pulmonary fibrosis Obstructive sleep apnea

Contacts and locations

Locations

  • University of Arizona

    Tucson, Arizona, 85724, United States

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