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

NCT05623709 | Terminated FDA Device

• 1 other identifier: Pro00118055
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Sleep Related Hypoventilation; Obstructive Sleep Apnea; Hypoventilation

Keywords

continuous positive airway pressure; bilevel positive airway pressure; noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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

  \[stratified by intervention with CPAP or NIV\]

  2 years

Secondary Outcomes (7)

• Proportion of patients with severe exacerbation of COPD (hospitalization/intensive care unit admission for COPD) in the 2 years following initiation of CPAP or NIV compared to the 2 years prior

  2 years

• Mean difference in the number of days hospitalized in the 2 years after the date of CPAP or NIV initiation or date of sleep diagnostic testing compared to the 2 years prior

  2 years

• Mean difference in hospitalizations/intensive care unit admissions for severe exacerbations of COPD in the 2 years after the date of CPAP or NIV initiation or date of sleep diagnostic testing compared to the 2 years prior

  2 years

• Mean difference in Emergency Department visits for moderate-severe exacerbations of COPD in the 2 years after the date of CPAP or NIV initiation or date of sleep diagnostic testing compared to the 2 years prior

  2 years

• Composite outcome of Emergency Department visits or hospitalizations following the date of NIV or CPAP initiation or date of sleep diagnostic testing

  2 years

Study Arms (2)

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.

Device: 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

Interventions

Positive airway pressure with continuous positive airway pressure or noninvasive ventilation DEVICE

CPAP or NIV prescribed by the treating respirologist for long-term use at home

Also known as: CPAP, NIV, PAP treatment

COPD and SRBD prescribed NIV or CPAP

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study setting are people living in Alberta receiving care by an adult respirologist who undergo sleep diagnostic testing, consent to contact for research at a participating site, are eligible for the study after a brief chart review, and who subsequently consent to be involved in the study. The start date for CPAP or NIV will need to be within the study period although it will not need to be after the date of sleep diagnostic testing in order to allow patients started on NIV in hospital who subsequently undergo sleep diagnostic testing to be eligible. Polysomnograms for eligible patients will be completed by sleep laboratories operating within Alberta Health Services within the public health care system. Home sleep apnea tests are performed by both private and public facilities within Alberta and both sites of testing will be considered adequate for patient inclusion in the study if that is the sole form of sleep diagnostic testing requested by the treating respirologist.

You may qualify if:

• 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.

You may not qualify if:

• Significant lung disease in addition to COPD
• Neuromuscular disease including diaphragmatic paralysis
• Dementia
• Treatment with CPAP or NIV for \>4 weeks prior to study eligibility.
• Refusal to participate
• Inability to consent in English and do not have an interpreter readily available
• Current diagnosis of an active malignancy
• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2G3, Canada

Location

Related Publications (23)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Hypoventilation

Interventions

Continuous Positive Airway Pressure; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 21, 2022
• Study Start: July 26, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)