TerminatedNot Applicable

Health Outcomes With CPAP or NIV in Patients With COPD and a Sleep Related Breathing Disorder

Stopped: Recruitment difficulties

Canada11 participantsStarted 2022-07-26

Plain-language summary

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting an estimated 1 in 10 Canadians. Symptoms include persistent shortness of breath, cough and sputum production. The symptoms can be serious when people with COPD experience a flare of their disease and may lead to hospitalization or death. Improving other conditions that affect COPD control is one way to improve the health of people with COPD. Obstructive sleep apnea (OSA) is the most common breathing problem during sleep, and commonly co-exists with COPD. Although diagnosing and treating OSA is encouraged, it has not been highlighted in guidelines that recommend ideal COPD care. People with COPD and OSA have lower sleep quality and lower oxygen levels during sleep compared to people with OSA. Despite these differences, treatment of OSA in people with COPD is modeled after treatment of OSA in the general population, generally using treatment with continuous positive airway pressure (CPAP) with the possible addition of oxygen through the CPAP machine. There are few studies looking at other types of treatment including noninvasive ventilation (NIV) in people with COPD and OSA. The majority of studies of NIV in COPD has been for people with other reasons to use NIV including acute respiratory failure or chronic hypercarbic respiratory failure and did not include people with risk factors for OSA or who had undergone overnight sleep studies. In Alberta, NIV is provided province wide for people who have both OSA who do not meet certain physiologic targets in their oxygen levels or breathing patterns after CPAP is applied on an overnight sleep study. NIV is provided preferentially to CPAP and oxygen, providing an opportunity to look at health outcomes when NIV is used instead of CPAP for the treatment of patients with COPD. Through this study, we will measure whether people with COPD and a sleep related breathing disorder such as OSA have fewer severe flares of COPD after starting CPAP or NIV. We will evaluate whether the number of Emergency Department visits, hospitalizations or deaths lowers after starting CPAP or NIV.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consenting adults who have completed polysomnography at the University of Alberta Sleep Disorders Laboratory in Edmonton, Alberta, Canada. * Naïve to CPAP or NIV therapy or have use of CPAP or NIV \<4 weeks in the past * Diagnosed with COPD by a respirologist and has fixed airflow obstruction on spirometry (i.e., post-bronchodilator FEV1/FVC \<LLN on spirometry or FEV1/FVC \<0.70 if the LLN is not provided) * Diagnosed with a SRBD for which CPAP or NIV are commonly prescribed, as defined below; some of the patients with mild SRBD or a SRBD suspected to be secondary to COPD rather than OSA (e.g. mild OSA, sustained hypercarbia, hypoxemia etc) may not be prescribed CPAP or NIV at the treating physician's discretion * OSA will be defined as a predominantly obstructive apnea-hypopnea index (AHI) ≥5 events/hr of sleep on sleep diagnostic testing in the presence of symptoms/relevant comorbidities or an AHI ≥15 events/hr irrespective of symptoms. If home sleep apnea testing was used in place of polysomnography, the respiratory event index (REI) will be a surrogate of AHI. * Hypoventilation will be defined by polysomnography criteria as a sustained elevation in the TcCO2 to be \>55 mmHg for ≥10 min or a rise in TcCO2 by \>10 mmHg to a value \>50 mmHg for ≥10 min. If an arterial blood gas is available, sustained hypercapnia as defined by arterial carbon dioxide oxygen tension (PaCO2) \>45 mmHg or serum bicarbonate (HCO3) ≥27 mmol/L while medically stable wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with moderate-severe exacerbations of COPD (Emergency Department visit for COPD) in the 2 years following initiation of CPAP or NIV compared to the 2 years prior

Timeframe: 2 years

Trial details

NCT IDNCT05623709

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-22

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials