Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD

Not Applicable

Terminated

• Conditions: Interstitial Lung Disease; Obstructive Sleep Apnea
• Interventions: Other: Withdrawal of Auto-CPAP; Device: Auto-CPAP

• Registration Number: NCT03901534
• Lead Sponsor: Columbia University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2023-01-01
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Results First Submitted: 2024-11-14
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2021

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Moderate to Severe OSA - withdrawal	Withdrawal of Auto-CPAP	Moderate-to-severe OSA Withdrawal of Auto-CPAP
Moderate to Severe OSA - treated	Auto-CPAP	Moderate-to-severe OSA Treated with and adherent to Auto-CPAP

Primary Outcome Measures

Name	Time	Method
Surfactant Protein D (SP-D) [Aim 1]	1 day	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.
E-selectin [Aim 1]	1 day	This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Angiopoietin-2 [Aim 1]	1 day	This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]	1 day	This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]	1 day	This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]	Baseline and post-CPAP follow-up, up to 24 Weeks	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.
Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]	Baseline and post-CPAP follow-up, up to 24 Weeks	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.
Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]	Baseline and post-CPAP follow-up, up to 24 Weeks	The between-arm difference in the longitudinal changes of Ang-2 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.
Change in Serum Osteopontin Following CPAP [Aim 2]	Baseline and post-CPAP follow-up, up to 24 Weeks	The differences between-arms in the longitudinal changes of Osteopontin 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.
Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]	Baseline and 4 weeks	Participants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy.; This Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.

Trial Locations

Locations (2)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States