Project Summary
PCORI supports Patient-Powered Research Networks (PPRNs), communities of patients participating in clinical research, as part of the National Patient-Centered Clinical Research Network (PCORnet). In 2017, PCORI launched an initiative on Partnerships to Conduct Research within PCORnet to support the PPRNs in conducting comparative clinical effectiveness research on questions that are important to patients and other stakeholders. The initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Chronic obstructive pulmonary disease, or COPD, and obstructive sleep apnea are long-term health problems that affect millions of people in the United States. Both health problems can make breathing hard and limit oxygen to the body. About 10 to 15 percent of people with COPD also have sleep apnea. People with both health problems have an increased risk of death. They also go to the hospital more often than people with either health problem alone.
Continuous positive airway pressure, or CPAP, therapy is one effective way to treat COPD and sleep apnea together. CPAP machines use mild air pressure to keep the airways open and help people breathe while sleeping. However, patients don’t always use CPAP therapy the right way.
In this study, the research team is testing two ways to help patients use CPAP therapy. The team is comparing how well each way improves CPAP use, sleep quality, and daytime sleepiness in patients with COPD and sleep apnea.
Who can this research help?
Results may help health clinic directors decide whether and how to support patients with COPD and sleep apnea.
What is the research team doing?
The research team is recruiting 330 patients from across the United States who have COPD and sleep apnea and use a CPAP machine. The team is assigning patients to one of two groups by chance. The first group gets access to the COPD Information Line, a telephone line staffed by peer coaches. Peer coaches are other patients with COPD and sleep apnea. The coaches receive 80 hours of training on topics such as disease management and customer service. They offer emotional support and advice about using the CPAP machine.
The second group gets access to the COPD Information Line plus access to an online portal. The portal has information on COPD and sleep apnea. The portal also includes online chat, email, and telephone support from two types of coaches: a peer coach and a respiratory therapist. Patients in the second group can also check their CPAP data online, such as whether they are using the CPAP machine properly. Patients in this group have weekly check-ins with their coaches.
The research team is comparing how long patients use their CPAP machine each day during the 6-week study to how long they used it during the 30 days before study. Then, 6 and 12 weeks after the study starts, the team is comparing sleep quality and daytime sleepiness between the two groups.
Patients with COPD and sleep apnea, healthcare providers, members of professional organizations, and medical equipment providers are helping to plan and design the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Adults over 40 years of age diagnosed with COPD and obstructive sleep apnea with a prescription for CPAP |
| Interventions/ Comparators |
|
| Outcomes |
Primary: CPAP adherence Secondary: daytime sleepiness, sleep quality |
 |
6-week follow-up for primary outcome |
Project Details
^David M. Mannino, MD, was the original principal investigator for this project.