Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
Condition: Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap Syndrome
MeSH terms: Lung Diseases; Sleep Apnea Syndromes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The coexistence 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.The investigators propose to conduct this study that aims: (1) to compare right
      and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in
      overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive
      airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)
      hemodynamics in overlap syndrome.

      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more
      RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and
      hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia
      alone in patients with overlap syndrome.
    

Detailed description: 
      Despite the high prevalence of overlap syndrome, few data are available on its
      pathophysiology and clinical consequences of these patients. Overlap syndrome has recently
      been reported to have excess cardiovascular mortality compared with COPD alone. However, no
      study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap
      syndrome. In addition, no prospective, randomized, controlled data are currently available on
      treatment of overlap syndrome.

      This study is divided into two parts. The first part (Part 1) is a cross-sectional cohort
      study comparing subjects with overlap syndrome to those with COPD alone and those with OSA
      alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep
      study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary
      function test, and questionnaires of sleep and health related quality of life. These
      measurement will be compared between overlap syndrome and control groups with either COPD or
      OSA alone.

      The second part (Part 2) of the study is a prospective, parallel-group, randomized,
      controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs.
      nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each
      treatment arm). The same measurement done during Part 1 will be repeated to evaluate the
      treatment effects.
    

Intervention name(s): Bi-level positive airway pressure (BPAP); Nocturnal oxygen
Intervention type(s): Device; Drug
Intervention description(s): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations <88% while on stable bi-level settings.; 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.
Other intervention name(s): BPAP; NOT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment