NCT03901534

Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,021 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (OSA) and interstitial lung disease (ILD).

Detailed description

This study is comprised of 3 aims: Aim 1: Determine whether the greater OSA severity is associated with higher levels of serum biomarkers of AEC and endothelial injury and ECM remodeling in community-dwelling adults. This is a retrospective study that will analyze biospecimens from those who participated in the MESA sleep study \[Chen et al\]. Aim 2: Determine whether CPAP use is associated with reductions in alveolar epithelial cell (AEC) injury and endothelial injury, and extracellular matrix (ECM) remodeling biomarkers in adults with moderate-to-severe OSA. This is a retrospective study that will analyze biospecimens from those who participated in either the HeartBEAT \[Gottlieb et al\] and BestAIR \[Bakker et al\] studies. Revised Aim 3: a) Determine whether untreated OSA promotes AEC and endothelial injury and ECM remodeling biomarkers in adults with ILD and OSA compared with those without OSA; b) Determine prospectively whether clinically-initiated 4-week PAP therapy increases markers of alveolar endothelial lung injury in OSA. Participants will be recruited at Columbia University and be assigned CPAP therapy as an intervention.

Conditions

• Interstitial Lung Disease
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure (CPAP) therapy	Standard, clinically used CPAP therapy. CPAP will be prescribed by the participants' clinician provider and not by the study investigators.
DEVICE	Nox A1 Recorder	Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2019-04-03
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study