Idiopathic Pulmonary FibrosisNCT05359965
Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
A study testing Positive Airway Pressure in people with Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea, run by University of Arizona at 1 site in United States.
Trial summary
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
- What is being tested?
- Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
Read the detailed description
Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.
- Being tested
- Positive Airway Pressure
- Keywords
- IPF, OSA, GERD
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Sleep Apnea, Obstructive, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway PressureDevice
Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks. Receives: Device: Positive Airway Pressure |
| No CPAP | No intervention | Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Biomarker Score
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)
Measured: 4-8 weeks
Secondary outcomes (9)
Biomarker of Lung Inflammation: KL-6
The value of KL-6 measured by ELISA in U/ml.
Measured: 4-8 weeks
Biomarker of Lung Inflammation: MMP1
The value of MMP1 measured by ELISA in ng/ml.
Measured: 4-8 weeks
Biomarker of Lung Inflammation: MMP7
The value of MMP7 measured by ELISA in ng/ml.
Measured: 4-8 weeks
Biomarker of Lung Inflammation: IL-8
The value of IL-8 measured by ELISA in pg/ml.
Measured: 4-8 weeks
Biomarker of Lung Inflammation: CXCL13
The value of CXCL-13 measured by ELISA in pg/ml.
Measured: 4-8 weeks
Esophageal pH During Sleep
Total sleep time (in minutes) with pH less than 4.
Measured: 4-8 weeks
24hr-Esophageal pH
Total time (minutes in 24hr period) with pH less than 4.
Measured: 4-8 weeks
FVC change
FVC change in percentage of predicted values over 6 months (baseline to 6 months).
Measured: 6 months
Composite Biomarker Score at Six Months
Weighted average of z-scores of the biomarkers MMP1, MMP7, IL8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker at six months. (Z-score is a unitless number, as is the weighted average.)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Oct 2019
- Primary completion26 Mar 2024
- Study completion11 Feb 2025
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to treatment groups using a 1:1 randomized block design via the randomization module in REDCap. The PI and study coordinator will be blinded to next assignment.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Sachin Chaudhary, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359965
- Sponsor's protocol ID
- IIS2018-10747
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2022
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT05359965
- Acronym / sponsor ID
- IIS2018-10747
- Keywords
- IPF, OSA, GERD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
Detailed description
Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be assigned to treatment groups using a 1:1 randomized block design via the randomization module in REDCap. The PI and study coordinator will be blinded to next assignment.
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: Positive Airway PressureSubjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks. |
| No CPAP | No intervention | –Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Airway PressureGentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping. | Device | CPAP |
Primary outcome
Composite Biomarker Score
Time frame: 4-8 weeks
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)
9 secondary outcomes
Biomarker of Lung Inflammation: KL-6
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: MMP1
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: MMP7
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: IL-8
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: CXCL13
Time frame: 4-8 weeks
Esophageal pH During Sleep
Time frame: 4-8 weeks
24hr-Esophageal pH
Time frame: 4-8 weeks
FVC change
Time frame: 6 months
Composite Biomarker Score at Six Months
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sachin Chaudhary, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure in people with Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Biomarker Score (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.