OSA COPD Overlap SyndromePAVE-OVSNCT07891962
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
A study testing high-intensity ventilation strategy and OSA-targeted ventilation strategy in people with OSA COPD Overlap Syndrome, run by University of British Columbia.
Trial summary
This pilot study compares two positive airway pressure strategies for patients with both COPD and obstructive sleep apnea (overlap syndrome) who retain excess carbon dioxide. Thirty-two patients will be randomly assigned to either CPAP or high-intensity bilevel ventilation (BiPAP) for 12 months. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- OSA COPD Overlap Syndrome
- What is being tested?
- high-intensity ventilation strategy and OSA-targeted ventilation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD (Global Initiative for Chronic Obstructive Lung Disease) Group C or D
- Daytime PvCO₂ > 50 mmHg in a stable clinical condition
- Obstructive sleep apnea with AHI ≥ 15 events/hour on polysomnography
- Body mass index ≥ 30 kg/m²
Who cannot join
- Conditions associated with central sleep apnea (central apnea index > 5 events/hour), e.g., left ventricular ejection fraction ≤ 45% or use of high-dose opioids (e.g., morphine)
- Current home use of positive airway pressure (PAP) therapy
- History of asthma
- Cognitive impairment or psychiatric disorders that preclude completion of the study protocol
- Pregnancy
- Other causes of hypercapnia, e.g., severe kyphoscoliosis or neuromuscular disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Continuous Positive Airway Pressure and Bilevel Ventilation Strategy Effectiveness in Hypercapnic Overlap Syndrome (PAVE-OVS): A Pilot Randomized Controlled Trial
This pilot study compares two positive airway pressure strategies for patients with both COPD and obstructive sleep apnea (overlap syndrome) who retain excess carbon dioxide. Thirty-two patients will be randomly assigned to either CPAP or high-intensity bilevel ventilation (BiPAP) for 12 months. The primary outcome is change in carbon dioxide levels. Secondary outcomes will be to evaluate the feasibility of conducting a larger multi-centre trial to guide treatment for this underserved population and other measures including sleep quality, respiratory symptoms, quality of life, treatment adherence, side effects, and safety.
Read the detailed description
Purpose: This pilot randomized controlled trial (RCT) compares two ventilation strategies delivered via bilevel positive airway pressure (BiPAP) in patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) overlap syndrome (OVS) with chronic stable hypercapnia. The two strategies are an OSA-targeted approach (low pressure support, functionally equivalent to continuous positive airway pressure [CPAP]) and a high-intensity ventilation approach (high pressure support targeting correction of alveolar hypoventilation).
Justification: Co-existence of COPD and OSA, termed overlap syndrome (OVS), is estimated to affect 1% of the general population, and approximately 40% of these patients develop chronic stable hypercapnia, which is associated with overall poor prognosis. OVS patients have significantly higher overall and cardiovascular mortality than patients with COPD or OSA alone. Despite the high prevalence and poor prognosis of OVS, limited research has been done to optimize therapy. In particular, OVS patients have been systematically excluded from clinical trials for both COPD and obesity hypoventilation syndrome (OHS) populations. Clinicians are currently left to extrapolate treatment recommendations for OVS from two related but contradictory evidence bases. The American Thoracic Society (ATS), Canadian Thoracic Society (CTS), and European Respiratory Society (ERS) guidelines for chronic stable hypercapnic COPD recommend non-invasive ventilation (NIV) with high-intensity settings, while ATS guidelines for OHS recommend CPAP for patients with coexisting severe OSA. A direct comparison of ventilation strategies in OVS with chronic stable hypercapnia has been identified as a high research priority by the ATS research statement on OVS. This pilot trial addresses that evidence gap and will inform the design of a future large multi-center RCT.
Hypothesis: Investigators hypothesize that the OSA-targeted and high-intensity ventilation strategies will demonstrate equivalent efficacy in correcting hypercapnia in patients with OVS.
Objectives: The primary objective is determine changes in CO₂ with an OSA-targeted ventilation strategy, with comparison to high-intensity ventilation over a 12-month follow-up period. The secondary objective will be to evaluate feasibility of a larger multi-site RCT. This would include participant recruitment metrics (number of patients screened and enrolled), protocol completion rates (including adherence to data collection instruments), and patient-reported measures such as quality of life (COPD- and sleep-specific questionnaires), NIV side effects, and adherence to therapy (e.g. % of patients fulfilling criteria of >4 hours/night).
Research Design: Investigators will conduct an open-label, parallel-group, single-center, pilot RCT. Patient inclusion criteria: 1) COPD GOLD (Global Initiative for Chronic Obstructive Lung Disease) C or D; 2) FEV1 < 50% predicted; 3) daytime PvCO2 (venous blood gas) on room air >50 mmHg; 4) OSA with moderate to severe obstructive AHI >=15event/hr based on PSG; 5) BMI >=30 kg/m2 6) Age >=40 years
Two arms (randomization to OSA-targeted vs high-intensity ventilation in a ratio of 1:1) will be compared. A titration polysomnography (PSG) will be conducted with the fitted mask to determine optimal device settings within 4 weeks of the baseline visit. Device data will be reviewed by study physicians initially weekly then monthly to adjust settings as needed to optimize treatment. Follow-up visits will be conducted at 1, 3, 6, and 12 months at the clinic and will include clinical assessment, venous blood gas, questionnaire administration, device adherence review, and adverse event monitoring. Feasibility outcomes including recruitment rate, protocol completion, and treatment adherence will be reported
- Conditions
- OSA COPD Overlap Syndrome
- Being tested
- high-intensity ventilation strategy, OSA-targeted ventilation strategy
- Keywords
- CPAP, BiPAP, hypercapnia
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity ventilation strategyDevice
Higher pressure support targeting increased tidal volume
OSA-targeted ventilation strategyDevice
Device settings are optimized to target upper airway obstruction
| Study group | Role | What they receive |
|---|---|---|
| OSA-targeted ventilation strategy | Active comparator | Bilevel settings optimized to specifically address upper airway obstruction Receives: Device: OSA-targeted ventilation strategy |
| high-intensity ventilation | Active comparator | Higher pressure support targeting increased tidal volume Receives: Device: high-intensity ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in venous carbon dioxide level
Determine changes in venous carbon dioxide value with an OSA-targeted ventilation strategy, with comparison to high-intensity ventilation
Measured: 12 months
Secondary outcomes (6)
Number of participants screened and enrolled
Number of participants screened for eligibility and number enrolled in the study.
Measured: 12 months
Severe Respiratory Insufficiency Questionnaire
The Severe Respiratory Insufficiency Questionnaire is scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 12 months
Protocol completion rate
Proportion of enrolled participants who completed the study protocol.
Measured: 12 months
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is scored on a scale of 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: 12 months
S3-Non Invasive Ventilation Questionnaire
The total score ranges from 0 to 10, with lower scores indicating greater discomfort associated with non-invasive ventilation device.
Measured: 12 months
Device adherence
The proportion of participants using the device for more than 4 hours per night.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OSA COPD Overlap SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditi Shah, University of British Columbia
- Investigators
- Aditi Shah, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891962
- Sponsor's protocol ID
- H26-01415
- Acronym
- PAVE-OVS
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the research team due to considerations regarding participant privacy and confidentiality. Aggregate results will be reported.
Publications
Mokhlesi B, Masa JF, Brozek JL, Gurubhagavatula I, Murphy PB, Piper AJ, Tulaimat A, Afshar M, Balachandran JS, Dweik RA, Grunstein RR, Hart N, Kaw R, Lorenzi-Filho G, Pamidi S, Patel BK, Patil SP, Pepin JL, Soghier I, Tamae Kakazu M, Teodorescu M. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2019 Aug 1;200(3):e6-e24. doi: 10.1164/rccm.201905-1071ST.
PubMed 31368798Macrea M, Oczkowski S, Rochwerg B, Branson RD, Celli B, Coleman JM 3rd, Hess DR, Knight SL, Ohar JA, Orr JE, Piper AJ, Punjabi NM, Rahangdale S, Wijkstra PJ, Yim-Yeh S, Drummond MB, Owens RL. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Aug 15;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST.
PubMed 32795139Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.
PubMed 30935737Malhotra A, Schwartz AR, Schneider H, Owens RL, DeYoung P, Han MK, Wedzicha JA, Hansel NN, Zeidler MR, Wilson KC, Badr MS; ATS Assembly on Sleep and Respiratory Neurobiology. Research Priorities in Pathophysiology for Sleep-disordered Breathing in Patients with Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2018 Feb 1;197(3):289-299. doi: 10.1164/rccm.201712-2510ST.
PubMed 29388824
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Continuous Positive Airway Pressure and Bilevel Ventilation Strategy Effectiveness in Hypercapnic Overlap Syndrome (PAVE-OVS): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07891962
- Acronym / sponsor ID
- PAVE-OVS / H26-01415
- Conditions
- OSA COPD Overlap Syndrome
- Keywords
- CPAP, BiPAP, hypercapnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study compares two positive airway pressure strategies for patients with both COPD and obstructive sleep apnea (overlap syndrome) who retain excess carbon dioxide. Thirty-two patients will be randomly assigned to either CPAP or high-intensity bilevel ventilation (BiPAP) for 12 months. The primary outcome is change in carbon dioxide levels. Secondary outcomes will be to evaluate the feasibility of conducting a larger multi-centre trial to guide treatment for this underserved population and other measures including sleep quality, respiratory symptoms, quality of life, treatment adherence, side effects, and safety.
Detailed description
Purpose: This pilot randomized controlled trial (RCT) compares two ventilation strategies delivered via bilevel positive airway pressure (BiPAP) in patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) overlap syndrome (OVS) with chronic stable hypercapnia. The two strategies are an OSA-targeted approach (low pressure support, functionally equivalent to continuous positive airway pressure [CPAP]) and a high-intensity ventilation approach (high pressure support targeting correction of alveolar hypoventilation).
Justification: Co-existence of COPD and OSA, termed overlap syndrome (OVS), is estimated to affect 1% of the general population, and approximately 40% of these patients develop chronic stable hypercapnia, which is associated with overall poor prognosis. OVS patients have significantly higher overall and cardiovascular mortality than patients with COPD or OSA alone. Despite the high prevalence and poor prognosis of OVS, limited research has been done to optimize therapy. In particular, OVS patients have been systematically excluded from clinical trials for both COPD and obesity hypoventilation syndrome (OHS) populations. Clinicians are currently left to extrapolate treatment recommendations for OVS from two related but contradictory evidence bases. The American Thoracic Society (ATS), Canadian Thoracic Society (CTS), and European Respiratory Society (ERS) guidelines for chronic stable hypercapnic COPD recommend non-invasive ventilation (NIV) with high-intensity settings, while ATS guidelines for OHS recommend CPAP for patients with coexisting severe OSA. A direct comparison of ventilation strategies in OVS with chronic stable hypercapnia has been identified as a high research priority by the ATS research statement on OVS. This pilot trial addresses that evidence gap and will inform the design of a future large multi-center RCT.
Hypothesis: Investigators hypothesize that the OSA-targeted and high-intensity ventilation strategies will demonstrate equivalent efficacy in correcting hypercapnia in patients with OVS.
Objectives: The primary objective is determine changes in CO₂ with an OSA-targeted ventilation strategy, with comparison to high-intensity ventilation over a 12-month follow-up period. The secondary objective will be to evaluate feasibility of a larger multi-site RCT. This would include participant recruitment metrics (number of patients screened and enrolled), protocol completion rates (including adherence to data collection instruments), and patient-reported measures such as quality of life (COPD- and sleep-specific questionnaires), NIV side effects, and adherence to therapy (e.g. % of patients fulfilling criteria of >4 hours/night).
Research Design: Investigators will conduct an open-label, parallel-group, single-center, pilot RCT. Patient inclusion criteria: 1) COPD GOLD (Global Initiative for Chronic Obstructive Lung Disease) C or D; 2) FEV1 < 50% predicted; 3) daytime PvCO2 (venous blood gas) on room air >50 mmHg; 4) OSA with moderate to severe obstructive AHI >=15event/hr based on PSG; 5) BMI >=30 kg/m2 6) Age >=40 years
Two arms (randomization to OSA-targeted vs high-intensity ventilation in a ratio of 1:1) will be compared. A titration polysomnography (PSG) will be conducted with the fitted mask to determine optimal device settings within 4 weeks of the baseline visit. Device data will be reviewed by study physicians initially weekly then monthly to adjust settings as needed to optimize treatment. Follow-up visits will be conducted at 1, 3, 6, and 12 months at the clinic and will include clinical assessment, venous blood gas, questionnaire administration, device adherence review, and adverse event monitoring. Feasibility outcomes including recruitment rate, protocol completion, and treatment adherence will be reported
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA-targeted ventilation strategy | Active comparator | Device: OSA-targeted ventilation strategyBilevel settings optimized to specifically address upper airway obstruction |
| high-intensity ventilation | Active comparator | Device: high-intensity ventilation strategyHigher pressure support targeting increased tidal volume |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD GOLD (Global Initiative for Chronic Obstructive Lung Disease) Group C or D
- Daytime PvCO₂ > 50 mmHg in a stable clinical condition
- Obstructive sleep apnea with AHI ≥ 15 events/hour on polysomnography
- Body mass index ≥ 30 kg/m²
Key exclusion criteria (6 listed)
- Conditions associated with central sleep apnea (central apnea index > 5 events/hour), e.g., left ventricular ejection fraction ≤ 45% or use of high-dose opioids (e.g., morphine)
- Current home use of positive airway pressure (PAP) therapy
- History of asthma
- Cognitive impairment or psychiatric disorders that preclude completion of the study protocol
- Pregnancy
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 |
|---|---|---|
| high-intensity ventilation strategyHigher pressure support targeting increased tidal volume | Device | high-intensity ventilation |
| OSA-targeted ventilation strategyDevice settings are optimized to target upper airway obstruction | Device | OSA-targeted ventilation strategy |
Primary outcome
changes in venous carbon dioxide level
Time frame: 12 months
Determine changes in venous carbon dioxide value with an OSA-targeted ventilation strategy, with comparison to high-intensity ventilation
6 secondary outcomes
Number of participants screened and enrolled
Time frame: 12 months
Severe Respiratory Insufficiency Questionnaire
Time frame: 12 months
Protocol completion rate
Time frame: 12 months
Epworth Sleepiness Scale
Time frame: 12 months
S3-Non Invasive Ventilation Questionnaire
Time frame: 12 months
Device adherence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 31368798Mokhlesi B, Masa JF, Brozek JL, Gurubhagavatula I, Murphy PB, Piper AJ, Tulaimat A, Afshar M, Balachandran JS, Dweik RA, Grunstein RR, Hart N, Kaw R, Lorenzi-Filho G, Pamidi S, Patel BK, Patil SP, Pepin JL, Soghier I, Tamae Kakazu M, Teodorescu M. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2019 Aug 1;200(3):e6-e24. doi: 10.1164/rccm.201905-1071ST.
- Background: PubMed 32795139Macrea M, Oczkowski S, Rochwerg B, Branson RD, Celli B, Coleman JM 3rd, Hess DR, Knight SL, Ohar JA, Orr JE, Piper AJ, Punjabi NM, Rahangdale S, Wijkstra PJ, Yim-Yeh S, Drummond MB, Owens RL. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Aug 15;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST.
- Background: PubMed 30935737Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.
- Background: PubMed 29388824Malhotra A, Schwartz AR, Schneider H, Owens RL, DeYoung P, Han MK, Wedzicha JA, Hansel NN, Zeidler MR, Wilson KC, Badr MS; ATS Assembly on Sleep and Respiratory Neurobiology. Research Priorities in Pathophysiology for Sleep-disordered Breathing in Patients with Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2018 Feb 1;197(3):289-299. doi: 10.1164/rccm.201712-2510ST.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the research team due to considerations regarding participant privacy and confidentiality. Aggregate results will be reported.
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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.
Aditi Shah, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity ventilation strategy and OSA-targeted ventilation strategy in people with OSA COPD Overlap Syndrome, run by University of British Columbia.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact University of British Columbia Hospital (604-822-7634, ubcsleepdisordersclinic@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in venous carbon dioxide level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07891962, which also lists 4 linked publications.
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 27 Oct 2026.