Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD
NCT ID: NCT03901534
Last Updated: 2024-12-20
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2021 participants
INTERVENTIONAL
2023-01-01
2023-10-16
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Community based Multi-Ethnic Study of Atherosclerosis (MESA)
This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont.
All participants in this cohort will be analyzed for only the Aim 1 outcome measures.
No interventions assigned to this group
HeartBEAT and BestAir
The cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \[Gottlieb et al\] and BestAIR \[Bakker et al\] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study.
Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine.
All participants in this cohort will be analyzed for only the Aim 2 outcome measures.
No interventions assigned to this group
CPAP treatment of OSA
Participants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP).
All participants in this cohort will be analyzed for only the Aim 3a outcome measures.
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.
ILD screening for OSA
Participants with interstitial lung disease (ILD) will be screened for OSA by polysomnography.
All participants in this cohort will be analyzed for only the Aim 3b outcome measures.
Nox A1 Recorder
Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.
Interventions
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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.
Nox A1 Recorder
Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.
Eligibility Criteria
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Inclusion Criteria
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
1. Age 18 years or greater
2. Clinical diagnosis of untreated OSA documented by nocturnal polysomnography
Exclusion Criteria
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
1. Current treatment with CPAP or oral appliance
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Columbia University
OTHER
Responsible Party
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Sanja Jelic
Associate Professor of Medicine
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Countries
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References
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Chen X, Wang R, Zee P, Lutsey PL, Javaheri S, Alcantara C, Jackson CL, Williams MA, Redline S. Racial/Ethnic Differences in Sleep Disturbances: The Multi-Ethnic Study of Atherosclerosis (MESA). Sleep. 2015 Jun 1;38(6):877-88. doi: 10.5665/sleep.4732.
Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAAR6902
Identifier Type: -
Identifier Source: org_study_id