Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT02244957
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 65
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap Syndrome	Device: Bi-level positive airway pressure (BPAP); Drug: Nocturnal oxygen	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP)	Device: Bi-level positive airway pressure (BPAP); 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.; Other Names: BPAP
Active Comparator: Nocturnal oxygen Nocturnal oxygen	Drug: Nocturnal oxygen; 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 Names: NOT

Outcome Measures

Primary Outcome Measures

1. Right Ventricular Remodeling Index [Six months]

   Defined as the ratio between RVMI and RV end-diastolic volume index using MRI

Secondary Outcome Measures

1. Right Ventricular Mass Index [Six months]

   MRI

2. Right Ventricular End Systolic and Diastolic Volume [Six months]

   MRI

3. Right Ventricular Ejection Fraction [Six months]

   MRI

4. Myocardial Extracellular Volume [Six months]

   MRI

5. Left Ventricular Remodeling Index [Six months]

   MRI

6. Left Ventricular Mass Index [Six months]

   MRI

7. Left Ventricular End Systolic and Diastolic Volume [6 months]

   MRI

8. Left Ventricular Ejection Fraction [6 months]

   MRI

9. Serum C-reactive Protein Level [6 months]

   blood test

10. Serum Tumor Necrosis Factor-alpha Level [6 months]

    blood test

11. Serum Interleukin-6 Level [6 months]

    blood test

12. Serum Intercellular Adhesion Molecule-1 [6 months]

    blood test

13. Serum P-selectin Level [6 months]

    Blood test

14. Urine Catecholamine Level [6 months]

    Urine test

15. 6 Minute Walk Distance [6 months]

    Low-grade physical activity test

16. Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ) [6 months]

    Questionnaire

17. Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS) [6 months]

    Questionnaire

18. Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI) [6 months]

    Questionnaire

19. General Health Status Through Short Form 36 (SF-36) Health Survey [6 months]

    Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Both men and women with age more than 18 years.

• Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.

Exclusion Criteria:

• Already using continuous positive airway pressure (CPAP), BPAP device, or nocturnal oxygen.

• Known or suspected renal failure with estimated Glomerular filtration (GFR) <50 ml/min/1.73 m2 or serum creatinine > 1.5 mg/dl.

• Chronic atrial fibrillation or frequent premature ventricular contraction (> 10 beats per hour)

• Women known to be pregnant or planning to be pregnant in next 6 months.

• Known contraindication to MRI: cardiac pacemaker, metallic heart valves, metallic implants, history of claustrophobia.

• If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.

• Uncontrolled COPD or acute COPD exacerbation.

• Unstable cardiac diseases.

• Known chronic inflammatory diseases like lupus or active infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: Robert L Owens, MD, UCSD

Study Documents (Full-Text)

• Study Protocol - Mar 25, 2014

More Information

Publications

None provided.

• Responsible Party: Robert L. Owens, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02244957
• Other Study ID Numbers: UCSD140959
• First Posted: Sep 19, 2014
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Lung Diseases; Sleep Apnea Syndromes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Study Results

Participant Flow

Arm/Group Title	Chronic Obstructive Pulmonary Disease (COPD)	Overlap Syndrome
Arm/Group Description	Subjects with only Chronic Obstructive Pulmonary Disease (COPD)	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.
Period Title: Overall Study
STARTED	7	16
COMPLETED	6	16
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Chronic Obstructive Pulmonary Disease (COPD)	Overlap Syndrome	Total
Arm/Group Description	Subjects with only Chronic Obstructive Pulmonary Disease (COPD).	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.	Total of all reporting groups
Overall Participants	6	16	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (6.4)	63.5 (4.2)	63.9 (5.8)
Sex: Female, Male (Count of Participants)
Female	5 83.3%	2 12.5%	7 31.8%
Male	1 16.7%	14 87.5%	15 68.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 16.7%	3 18.8%	4 18.2%
Not Hispanic or Latino	5 83.3%	13 81.3%	18 81.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%	16 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Right Ventricular Remodeling Index
Description	Defined as the ratio between RVMI and RV end-diastolic volume index using MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

one subject was dropped due to lack of efficacy

Arm/Group Title	Chronic Obstructive Pulmonary Disease (COPD)	Overlap Syndrome
Arm/Group Description	Subjects with only Chronic Obstructive Pulmonary Disease (COPD).	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.
Measure Participants	6	16
Mean (Standard Deviation) [ratio]	0.3747 (0.06335)	0.2817 (0.03630)

2. Secondary Outcome

Title	Right Ventricular Mass Index
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

3. Secondary Outcome

Title	Right Ventricular End Systolic and Diastolic Volume
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Right Ventricular Ejection Fraction
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

5. Secondary Outcome

Title	Myocardial Extracellular Volume
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

6. Secondary Outcome

Title	Left Ventricular Remodeling Index
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

7. Secondary Outcome

Title	Left Ventricular Mass Index
Description	MRI
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

8. Secondary Outcome

Title	Left Ventricular End Systolic and Diastolic Volume
Description	MRI
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

9. Secondary Outcome

Title	Left Ventricular Ejection Fraction
Description	MRI
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

10. Secondary Outcome

Title	Serum C-reactive Protein Level
Description	blood test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

11. Secondary Outcome

Title	Serum Tumor Necrosis Factor-alpha Level
Description	blood test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

12. Secondary Outcome

Title	Serum Interleukin-6 Level
Description	blood test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

13. Secondary Outcome

Title	Serum Intercellular Adhesion Molecule-1
Description	blood test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

14. Secondary Outcome

Title	Serum P-selectin Level
Description	Blood test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

15. Secondary Outcome

Title	Urine Catecholamine Level
Description	Urine test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

16. Secondary Outcome

Title	6 Minute Walk Distance
Description	Low-grade physical activity test
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

17. Secondary Outcome

Title	Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)
Description	Questionnaire
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

18. Secondary Outcome

Title	Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)
Description	Questionnaire
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

19. Secondary Outcome

Title	Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)
Description	Questionnaire
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

20. Secondary Outcome

Title	General Health Status Through Short Form 36 (SF-36) Health Survey
Description	Questionnaire
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No data collected as study was terminated prior to randomization

Arm/Group Title	Bi-level Positive Airway Pressure (BPAP)	Nocturnal Oxygen
Arm/Group Description	Bi-level positive airway pressure (BPAP) Bi-level positive airway pressure (BPAP): 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.	Nocturnal oxygen Nocturnal oxygen: 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.
Measure Participants	0	0

Adverse Events

Time Frame	6 months
Arm/Group Title	Chronic Obstructive Pulmonary Disease (COPD)		Overlap Syndrome
Arm/Group Description	Subjects with only Chronic Obstructive Pulmonary Disease (COPD)		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.
All Cause Mortality
	Chronic Obstructive Pulmonary Disease (COPD)		Overlap Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/16 (0%)
Serious Adverse Events
	Chronic Obstructive Pulmonary Disease (COPD)		Overlap Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Chronic Obstructive Pulmonary Disease (COPD)		Overlap Syndrome
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.