Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD

Columbia University2,021 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,021

Conditions

Interstitial Lung Disease Obstructive Sleep Apnea

Interventions

Continuous positive airway pressure (CPAP) therapyDEVICE

Standard, clinically used CPAP therapy. CPAP will be prescribed by the participants' clinician provider and not by the study investigators.

Nox A1 RecorderDEVICE

Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for Patients with ILD: 1. Ability to provide informed consent. 2. Age 18 years or greater 3. Diagnosis of any of the following fibrotic interstitial lung diseases as defined by ATS/ERS/JRS/ALAT guidelines and research statements and Delphi surveys: * Idiopathic pulmonary fibrosis * Idiopathic non-specific interstitial pneumonia (NSIP) with fibrosis * Chronic hypersensitivity pneumonitis with fibrosis * Connective tissue disease related interstitial lung disease (CTD-ILD) * Unclassifiable idiopathic interstitial pneumonia with fibrosis Exclusion criteria for Patients with ILD: 1. Clinically significant lung disease other than fibrotic interstitial lung disease 2. Planned change to the IPF treatment during the study period 3. Current cigarette smoking (past 4 weeks) 4. Lower respiratory tract infection in past 60 days. (Upper respiratory tract infection is not a contraindication) 5. History of life-threatening cardiac arrhythmias 6. Known chronic heart failure (LVEF \< 45% or echo evidence of RV dysfunction or PH) 7. Chronic opiate analgesic use 8. History of sleepiness-related automobile accident within past year of enrollment 9. Expected survival time in the opinion of the investigator of less than 6 months 10. History of stroke or spinal cord injury Inclusion criteria for OSA patients: 1. Age 18 years or greater 2. Clinical diagnosis of untreated OSA documented by nocturnal polysomnography Exclusion criteria for OSA patients: 1. Current treatment with CPAP or oral appliance 2. Identical exclusion criteria as for ILD patients

Locations (2)

Brigham & Women's Hospital

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Surfactant Protein D (SP-D) [Aim 1]

SP-D is a marker of alveolar epithelial cell injury. This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.

Time frame: 1 day

E-selectin [Aim 1]

This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.

Time frame: 1 day

Angiopoietin-2 [Aim 1]

This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.

Time frame: 1 day

Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]

This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.

Time frame: 1 day

Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]

This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.

Time frame: 1 day

Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]

The differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.

Time frame: Baseline and post-CPAP follow-up, up to 24 Weeks

Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]

The between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.

Data from ClinicalTrials.gov

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