Obstructive Sleep ApneaNCT02244957
Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
A study testing Bi-level positive airway pressure (BPAP) and Nocturnal oxygen in people with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Overlap Syndrome
- What is being tested?
- Bi-level positive airway pressure (BPAP) and Nocturnal oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both men and women with age more than 18 years.
- Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.
Who cannot join
- 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.
Show all 9Show fewer
- Uncontrolled COPD or acute COPD exacerbation.
- Unstable cardiac diseases.
- Known chronic inflammatory diseases like lupus or active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
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.
Read the 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.
- Being tested
- Bi-level positive airway pressure (BPAP), Nocturnal oxygen
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-level positive airway pressure (BPAP)Device
Also called 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 oxygenDrug
Also called NOT
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.
| Study group | Role | What they receive |
|---|---|---|
| Bi-level positive airway pressure (BPAP) | Active comparator | Bi-level positive airway pressure (BPAP) Receives: Device: Bi-level positive airway pressure (BPAP) |
| Nocturnal oxygen | Active comparator | Nocturnal oxygen Receives: Drug: Nocturnal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricular Remodeling Index
Defined as the ratio between RVMI and RV end-diastolic volume index using MRI
Measured: Six months
Secondary outcomes (19)
Right Ventricular Mass Index
MRI
Measured: Six months
Right Ventricular End Systolic and Diastolic Volume
MRI
Measured: Six months
Right Ventricular Ejection Fraction
MRI
Measured: Six months
Myocardial Extracellular Volume
MRI
Measured: Six months
Left Ventricular Remodeling Index
MRI
Measured: Six months
Left Ventricular Mass Index
MRI
Measured: Six months
Left Ventricular End Systolic and Diastolic Volume
MRI
Measured: 6 months
Left Ventricular Ejection Fraction
MRI
Measured: 6 months
Serum C-reactive Protein Level
blood test
Measured: 6 months
Serum Tumor Necrosis Factor-alpha Level
blood test
Measured: 6 months
Serum Interleukin-6 Level
blood test
Measured: 6 months
Serum Intercellular Adhesion Molecule-1
blood test
Measured: 6 months
Serum P-selectin Level
Blood test
Measured: 6 months
Urine Catecholamine Level
Urine test
Measured: 6 months
6 Minute Walk Distance
Low-grade physical activity test
Measured: 6 months
Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)
Questionnaire
Measured: 6 months
Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)
Questionnaire
Measured: 6 months
Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)
Questionnaire
Measured: 6 months
General Health Status Through Short Form 36 (SF-36) Health Survey
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2017
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert L Owens, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244957
- Sponsor's protocol ID
- UCSD140959
- Status last verified
- Jul 2020
- First submitted
- 15 Sep 2014
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02244957
- Acronym / sponsor ID
- UCSD140959
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 28 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-level positive airway pressure (BPAP) | Active comparator | Device: Bi-level positive airway pressure (BPAP)Bi-level positive airway pressure (BPAP) |
| Nocturnal oxygen | Active comparator | Drug: Nocturnal oxygenNocturnal oxygen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both men and women with age more than 18 years.
- Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-level positive airway pressure (BPAP)Also: BPAPOverlap 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. | Device | Bi-level positive airway pressure (BPAP) |
| Nocturnal oxygenAlso: NOTOxygen 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. | Drug | Nocturnal oxygen |
Primary outcome
Right Ventricular Remodeling Index
Time frame: Six months
Defined as the ratio between RVMI and RV end-diastolic volume index using MRI
19 secondary outcomes
Right Ventricular Mass Index
Time frame: Six months
Right Ventricular End Systolic and Diastolic Volume
Time frame: Six months
Right Ventricular Ejection Fraction
Time frame: Six months
Myocardial Extracellular Volume
Time frame: Six months
Left Ventricular Remodeling Index
Time frame: Six months
Left Ventricular Mass Index
Time frame: Six months
Left Ventricular End Systolic and Diastolic Volume
Time frame: 6 months
Left Ventricular Ejection Fraction
Time frame: 6 months
Serum C-reactive Protein Level
Time frame: 6 months
Serum Tumor Necrosis Factor-alpha Level
Time frame: 6 months
Serum Interleukin-6 Level
Time frame: 6 months
Serum Intercellular Adhesion Molecule-1
Time frame: 6 months
Serum P-selectin Level
Time frame: 6 months
Urine Catecholamine Level
Time frame: 6 months
6 Minute Walk Distance
Time frame: 6 months
Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)
Time frame: 6 months
Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)
Time frame: 6 months
Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
General Health Status Through Short Form 36 (SF-36) Health Survey
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Owens, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-level positive airway pressure (BPAP) and Nocturnal oxygen in people with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Ventricular Remodeling Index (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.