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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-level positive airway pressure (BPAP) | Active Comparator | Bi-level positive airway pressure (BPAP) |
|
| Nocturnal oxygen | Active Comparator | Nocturnal oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-level positive airway pressure (BPAP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Remodeling Index | Defined as the ratio between RVMI and RV end-diastolic volume index using MRI | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Mass Index | MRI | Six months |
| Right Ventricular End Systolic and Diastolic Volume | MRI | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Owens, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Obstructive Pulmonary Disease (COPD) | Subjects with only Chronic Obstructive Pulmonary Disease (COPD) |
| FG001 | Overlap Syndrome | Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
one subject was dropped due to lack of efficacy
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Obstructive Pulmonary Disease (COPD) | Subjects with only Chronic Obstructive Pulmonary Disease (COPD). |
| BG001 | Overlap Syndrome | Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Right Ventricular Remodeling Index | Defined as the ratio between RVMI and RV end-diastolic volume index using MRI | one subject was dropped due to lack of efficacy | Posted | Mean | Standard Deviation | ratio | Six months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Obstructive Pulmonary Disease (COPD) | Subjects with only Chronic Obstructive Pulmonary Disease (COPD) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dillon Gilbertson | UCSD | 8582452155 | dcgilbertson@health.ucsd.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2014 | May 28, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Nocturnal oxygen | Drug | 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. |
|
|
| Right Ventricular Ejection Fraction | MRI | Six months |
| Myocardial Extracellular Volume | MRI | Six months |
| Left Ventricular Remodeling Index | MRI | Six months |
| Left Ventricular Mass Index | MRI | Six months |
| Left Ventricular End Systolic and Diastolic Volume | MRI | 6 months |
| Left Ventricular Ejection Fraction | MRI | 6 months |
| Serum C-reactive Protein Level | blood test | 6 months |
| Serum Tumor Necrosis Factor-alpha Level | blood test | 6 months |
| Serum Interleukin-6 Level | blood test | 6 months |
| Serum Intercellular Adhesion Molecule-1 | blood test | 6 months |
| Serum P-selectin Level | Blood test | 6 months |
| Urine Catecholamine Level | Urine test | 6 months |
| 6 Minute Walk Distance | Low-grade physical activity test | 6 months |
| Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ) | Questionnaire | 6 months |
| Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS) | Questionnaire | 6 months |
| Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI) | Questionnaire | 6 months |
| General Health Status Through Short Form 36 (SF-36) Health Survey | Questionnaire | 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Right Ventricular Mass Index | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Right Ventricular End Systolic and Diastolic Volume | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Right Ventricular Ejection Fraction | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Myocardial Extracellular Volume | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Left Ventricular Remodeling Index | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Left Ventricular Mass Index | MRI | No data collected as study was terminated prior to randomization | Posted | Six months |
|
|
| Secondary | Left Ventricular End Systolic and Diastolic Volume | MRI | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Left Ventricular Ejection Fraction | MRI | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Serum C-reactive Protein Level | blood test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Serum Tumor Necrosis Factor-alpha Level | blood test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Serum Interleukin-6 Level | blood test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Serum Intercellular Adhesion Molecule-1 | blood test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Serum P-selectin Level | Blood test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Urine Catecholamine Level | Urine test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | 6 Minute Walk Distance | Low-grade physical activity test | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ) | Questionnaire | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS) | Questionnaire | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI) | Questionnaire | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| Secondary | General Health Status Through Short Form 36 (SF-36) Health Survey | Questionnaire | No data collected as study was terminated prior to randomization | Posted | 6 months |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Overlap Syndrome | Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |