A Phase 1/2 interventional study of Bi-level positive airway pressure (BPAP) and Oxygen in Chronic Obstructive Airway Disease, sponsored by Brigham and Women's Hospital. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Brigham and Women's Hospital · Phase 1/2, Interventional, and Treatment
Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the impact of intervention on cardiac MRI and biomarkers.
Presence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population. Despite the high prevalence of overlap syndrome, little research has been done in this field. Overlap syndrome has been recently reported to have higher death rate than COPD alone, which is due to effect on the heart. However, the mechanisms by which overlap syndrome affects the heart are not known well. Also, the ideal treatment for overlap syndrome is not known.
This study is being done to find the mechanisms by which overlap syndrome affects the right and left sides of heart (using cardiac MRI to study the heart). We will also compare the effect of treatment with bi-level positive airway pressure device (BPAP) vs. night-time oxygen on heart in overlap syndrome. These aims will allow us to test the hypothesis that overlap syndrome patients have worse heart function than COPD only or OSA only, and treatment with BPAP device will improve the heart function better than oxygen only.
At the baseline visit, the subject will undergo an overnight sleep study in the hospital. In the morning, blood draw to measure serum inflammatory biomarkers (C-Reactive Protein, interleukin-6, P-selectin, ICAM-1, TNF-alpha), urine catecholamine level, six-minute walk test, questionnaire for health-related quality of life score and modified Medical Research Council (MMRC) dyspnea score, lung function tests, ultrasound of forearm blood vessels and cardiac MRI will be done. No follow-up visit is needed if the subject does not have sleep apnea. If the subject has sleep apnea based on the sleep study, he/she will be allotted to treatment with a BPAP device or night-time oxygen for 6 months. If the subject does not want to be treated with BPAP or oxygen, CPAP device will be used to treat sleep apnea. During the duration of study treatment, phone calls and a brief study visit at 3 months will be done to make sure there is no discomfort related to the treatment. After 6 months of study treatment, cardiac MRI, ultrasound of forearm blood vessels, lung function tests, blood draw for serum inflammatory biomarkers, urine catecholamine level, six-minute walk test, and questionnaires for dyspnea score and quality of life score will be repeated.
This study will help us in better understanding of mechanisms of high death rate due to effects on the heart in overlap syndrome. It will also help us in understanding better ways to treat sleep apnea in COPD patients.
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Exclusion Criteria:
bi-level will be titrated to optimize oxygenation and ventilation.
Device: Bi-level positive airway pressure (BPAP)
oxygen will be provided as per standard of care.
Drug: Oxygen
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
Device: CPAP
The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months.
Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
Right ventricular end-diastolic volume
Time frame: Six months
Other cardiac hemodynamics parameters (end-systolic volume, ejection fraction, mass index and wall motion of right and left ventricles, coronary blood flow, pulmonary artery pressure and blood flow, etc.)
Time frame: Six months
Serum inflammatory biomarkers (C-reactive protein, interleukin-6, ICAM-1 and P-selectin)
Time frame: Six months
Urine catecholamine level
Time frame: Six months
Flow mediated dilatation of brachial artery
Time frame: Six months
Pulmonary Function tests
Time frame: Six months
BODE Index
Time frame: Six months
Plan to share: No — nothing to include
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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