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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

ACT-IPF Trial 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.Check my eligibility
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.See study design
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.

ACT-IPF Trial Eligibility Criteria

Inclusion Criteria

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

ACT-IPF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Concentration of CA125 (U/mL)
Concentration of CA19-9 (U/mL)
Concentration of Osteopontin (ng/mL)
+1 more

ACT-IPF 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
1,433 Previous Clinical Trials
2,460,850 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,692 Total Patients Enrolled
Sanja Jelic, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
299 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for volunteers in this clinical trial?

"Clinicaltrials.gov affirms that this experiment is still in need of participants; it was initially established on October 1st 2022 and its details were recently revised on March 25th 2022."

Answered by AI

What goal is this medical experiment aiming to accomplish?

"The primary goal of this 24-week trial is to measure serum surfactant protein A. Secondary outcomes encompass a Cough Visual Analog Scale (ranging from 0 [no cough] to 100 [severe cough]), University of California San Diego Shortness of Breath Questionnaire score (0 - 120), and Epworth Sleepiness Scale score (0 - 24)."

Answered by AI

What is the utmost amount of participants currently participating in this trial?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, first posted in October 1st 2022, is currently recruiting volunteers. An estimated 165 participants need to be enrolled from one specific healthcare facility."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Assessment of Continuous Positive Airway Pressure Therapy in IPF
Sanja Jelic 2023. "Assessment of Continuous Positive Airway Pressure Therapy in IPF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03901534.
All > Lung Disease
~57 spots leftby Dec 2024
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