Assessment of Continuous Positive Airway Pressure Therapy in IPF (ACT-IPF)

  • STATUS
    Recruiting
  • End date
    Jul 13, 2023
  • participants needed
    165
  • sponsor
    Columbia University
Updated on 13 April 2022
pulmonary fibrosis
fibrosis
idiopathic pulmonary fibrosis

Summary

The purpose of this study is to evaluate whether biomarkers of lung injury and remodeling are responsive to effective continuous positive airway pressure (CPAP) treatment in adults with idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA).

Description

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic disease of the peripheral lung parenchyma that affects 0.5% of older adults in the U.S. and confers a very poor median survival. Repetitive injury to the lung with abnormal healing likely results in fibrosis as treatment of those risk factors that cause these injuries may improve outcomes. Obstructive sleep apnea (OSA), a form of sleep disordered breathing, is highly prevalent in adults with IPF and may be a risk factor in IPF by exerting peripheral tractional stress on the lung and promoting oxidative injury by intermittent hypoxia. Effective treatment of OSA with continuous positive airway pressure (CPAP) reduces the number of obstructive events in OSA and therefore may reduce repetitive injury to the lung in adults with IPF.

Participants in this study will undergo polysomnography to determine whether they have OSA, and if so, its severity based on the apnea-hypopnea index (AHI, events/ hour). Those participants with moderate-to-severe OSA will undergo CPAP treatment for up to 48 weeks with an interim period of withdrawal of CPAP. The primary aim of this study will examine the effect of CPAP treatment and its withdrawal and re-initiation on biomarkers of lung injury and remodeling in adults with IPF and moderate-to-severe OSA who are adherent to CPAP (expected sample size for this group is 30). The study will stop enrollment after 30 participants in this group are enrolled.

Details
Condition Interstitial Lung Disease, Obstructive Sleep Apnea
Treatment Auto-CPAP, Withdrawal of Auto-CPAP
Clinical Study IdentifierNCT03901534
SponsorColumbia University
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent
Age equal to or greater than 50 years
Diagnosis of IPF as defined by the 2018 ATS/ERS/JRS/ALAT guidelines

Exclusion Criteria

Clinically significant lung disease other than IPF
Planned change to the IPF treatment during the study period
Known contraindication to CPAP
Current use of CPAP, an oral appliance, or hypoglossal nerve stimulation for treatment of OSA
Current cigarette smoking (past 4 weeks)
Lower respiratory tract infection in the past 60 days. (Upper respiratory tract infection is not a contraindication)
History of life-threatening cardiac arrhythmias
Known chronic heart failure (Left ventricle ejection fraction < 45% or echo evidence of right ventricle dysfunction or pulmonary hypertension)
Chronic opiate analgesic use
History of stroke or spinal cord injury
History of sleepiness-related automobile accident within past year of enrollment
Expected survival time in the opinion of the investigator of less than 6 months
Commercial driver's license or occupation
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