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CPAP Therapy for Interstitial Lung Disease and Sleep Apnea (ACT-IPF Trial)

N/A
Recruiting
Led By Sanja Jelic, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age equal to or greater than 50 years
Diagnosis of IPF as defined by the 2018 ATS/ERS/JRS/ALAT guidelines
Must not have
Known chronic heart failure (Left ventricle ejection fraction < 45% or echo evidence of right ventricle dysfunction or pulmonary hypertension)
Commercial driver's license or occupation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether CPAP is effective in treating IPF and OSA by measuring biomarkers of lung injury and remodeling.

Who is the study for?
This trial is for adults over 50 with idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA). Participants must not have other significant lung diseases, changes in IPF treatment during the study, a history of smoking or recent respiratory infections, use opiates regularly, or have certain cardiovascular conditions.
What is being tested?
The study tests if biomarkers indicating lung injury change when using Auto-CPAP therapy. It involves adults with IPF and OSA to see if CPAP can help reduce signs of lung damage by comparing patients who continue versus those who withdraw from CPAP treatment.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with CPAP include discomfort or irritation where the mask touches the face, dry nose or throat, nasal congestion, headaches and sometimes stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.
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I have been diagnosed with IPF according to the latest guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chronic heart failure with specific heart function measurements.
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I have a commercial driver's license or my job requires one.
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I plan to change my IPF treatment during the study.
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I have had a stroke or spinal cord injury in the past.
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I have a lung condition that is not IPF.
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I use a CPAP machine, oral appliance, or nerve stimulation device for sleep apnea.
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I have had serious heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum Angiopoietin-2 (Ang-2, ng/mL)
Serum matrix metalloproteinase-7 (MMP-7, ng/mL)
Serum surfactant protein-A (SP-A, ng/mL)
+1 more
Secondary study objectives
Assess Quality of life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)
Cough Visual Analog Scale
Diffusing capacity of the lung for carbon monoxide (DLCO)
+6 more
Other study objectives
Concentration of CA125 (U/mL)
Concentration of CA19-9 (U/mL)
Concentration of Osteopontin (ng/mL)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Moderate to Severe OSA - withdrawalExperimental Treatment1 Intervention
Moderate-to-severe OSA Withdrawal of Auto-CPAP
Group II: Moderate to Severe OSA - treatedExperimental Treatment1 Intervention
Moderate-to-severe OSA Treated with and adherent to Auto-CPAP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auto-CPAP
2017
N/A
~110

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,489 Previous Clinical Trials
2,663,798 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,936 Previous Clinical Trials
47,792,488 Total Patients Enrolled
Sanja Jelic, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
299 Total Patients Enrolled
~7 spots leftby Dec 2024
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