Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea

NCT07891962 | Not Yet Recruiting

• 1 other identifier: H26-01415
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

OSA COPD Overlap Syndrome

Keywords

CPAP; BiPAP; hypercapnia

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (6)

• Number of participants screened and enrolled

  12 months

• Severe Respiratory Insufficiency Questionnaire

  12 months

• Protocol completion rate

  12 months

• Epworth Sleepiness Scale

  12 months

• S3-Non Invasive Ventilation Questionnaire

  12 months

Study Arms (2)

OSA-targeted ventilation strategy

ACTIVE COMPARATOR

Bilevel settings optimized to specifically address upper airway obstruction

Device: Bilevel

high-intensity ventilation

ACTIVE COMPARATOR

Higher pressure support targeting increased tidal volume

Device: Bilevel

Interventions

Bilevel DEVICE

Bilevel device can be used for ventilation support to address upper airway obstruction, augment tidal volume.

OSA-targeted ventilation strategy; high-intensity ventilation

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (4)

• 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.

  PMID: 31368798 BACKGROUND

• Macrea 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.

  PMID: 32795139 BACKGROUND

• Masa 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.

  PMID: 30935737 BACKGROUND

• Malhotra 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.

  PMID: 29388824 BACKGROUND

MeSH Terms

Conditions

Hypercapnia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Aditi Shah, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

University of British Columbia Hospital

CONTACT

604-822-7634; ubcsleepdisordersclinic@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share