Health Outcomes With CPAP or NIV in Patients With COPD and a Sleep Related Breathing Disorder
Key facts
- Who runs it
- University of Alberta
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 11 people enrolled
- Started
- 26 Jul 2022
- Ended
- 22 Mar 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Positive airway pressure with continuous positive airway pressure or noninvasive ventilation
- Record updated
- 26 March 2024
- Why it stopped
- Recruitment difficulties
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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 will be reported
Who cannot take part
- Treatment with CPAP or NIV for >4 weeks prior to study eligibility
- Significant lung disease in addition to COPD
- Neuromuscular disease including diaphragmatic paralysis
- Dementia
- Current diagnosis of an active malignancy
- Refusal to participate
- Inability to consent in English and do not have an interpreter readily available
- Central sleep apnea as the indication for PAP treatment. Central sleep apnea will be defined as a central hypopnea index ≥5 events/hr of sleep on polysomnography and the number of central apneas and/or central hypopneas is >50% of the AHI with or without Cheyne-Stokes breathing
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- COPD and SRBD prescribed NIV or CPAP
Group 1a: (n=55) Adults with a SRBD and COPD who are newly prescribed NIV treatment within the study period. Group 1b: (n=55) Adults with a SRBD and COPD who are newly prescribed CPAP treatment within the study period.
Treatment: Positive airway pressure with continuous positive airway pressure or noninvasive ventilation
- COPD controls not prescribed CPAP or NIV
Group 2: COPD controls without a SRBD: (n=55) Adults with COPD who undergo sleep diagnostic testing and who are not recommended to start CPAP or NIV
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Health Outcomes Following Treatment With Continuous Positive Airway Pressure or Noninvasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease and a Sleep Related Breathing Disorder
- Record updated
- 26 March 2024