Sleep Sessions Examine Clinical Trial

An ATS 2014 scientific symposium today and a mini-symposium on Tuesday morning will shed light on the growing number of clinical trials in pulmonary sleep medicine.

“While research presented in previous years has focused on observational studies and clinical physiology in sleep medicine, this year’s conference is highlighted by a large number of clinical trials,” says Christopher O’Donnell, PhD, professor of medicine at the University of Pittsburgh and the ATS Assembly on Sleep and Respiratory Neurobiology Program Committee chair.

Six experts in comparative effectiveness research (CER) in sleep medicine will discuss recent landmark studies in adult and pediatric sleep medicine during “Comparative Effectiveness Trials in Sleep Medicine: Results from Recent Studies and Future Directions” from 8:15 to 10:45 a.m. today in Indigo Ballroom B-C (Level 2) Hilton San Diego Bayfront.

The symposium will be co-moderated by Nick Antic, PhD, MBBS, associate professor and clinical director of the Adelaide Institute for Sleep Health at Repatriation General Hospital, and Susan Redline, MD, MPH, the Peter C. Farrell Professor of Sleep Medicine at Harvard Medical School, Boston.

“CER has become increasingly important around the world in recent years,” says Dr. Antic, also a staff specialist in sleep and respiratory medicine at the Southern Adelaide Local Health Network, Adelaide, Australia.

“The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at the individual and population levels,” he says.

Dr. Antic adds that the passing of the American Recovery and Reinvestment Act of 2009 allotted $1.1 billion to support this research. “The speakers will present the rationale, processes, and results from their CER studies, which have been published in high impact journals in the last 12 months,” Dr. Antic notes.

The symposium, sponsored by the Assemblies on Sleep and Respiratory Neurobiology; Behavioral Science and Health Services Research; and Clinical Problems, will conclude with “Comparative Effectiveness Research in Sleep Medicine: Lessons Learned and Future Directions.”

“Dr. Redline will discuss the importance of CER and how to perform these studies, including funding sources, monitoring, randomization, ethics of observations and control arm, when to use a data and safety monitoring board, and, most importantly, future areas of priority for CER in sleep medicine,” Dr. Antic says.

A mini-symposium from 2 to 4:30 p.m. Monday in Indigo Ballroom B-C (Level 2) Hilton San Diego Bayfront will tackle “Randomized Controlled and Prospective Clinical Trials in Sleep Disordered Breathing.”

“This session contains no less than eight randomized controlled clinical trials with a focus on CPAP, the often poorly adhered to, but nonetheless first-line, treatment option for obstructive sleep apnea,” Dr. O’Donnell says.

Two RCTs examine the adherence of CPAP in older patients and explore the use of zoplicone to improve adherence. Other RCTs determine the cost-effectiveness of CPAP treatment and evaluate the role of the primary care physician versus the sleep specialist in the management of CPAP therapy.

There are also RCTs that investigate the role of oxygen therapy as an alternative treatment strategy to CPAP in subphenotypes of sleep apnea patients, and the potential use of statins in mitigating biomarkers of cardiovascular disease.

“This mini-symposium will provide attendees with breaking trial data to inform on the application, management, and cost-effectiveness of CPAP therapy, as well as explore alternative treatment options for obstructive sleep apnea and its associated cardiovascular risk,” Dr. O’Donnell says.

On Tuesday, the symposium on “Controversies in Obstructive Sleep Apnea Management: Pro-Con” will bring together a patient perspective and four pro-con debates. The session will be from 8:15 to 10:45 a.m. in Indigo Ballroom B-C (Level 2) Hilton San Diego Bayfront.

It is sponsored by the Assembly on Sleep and Respiratory Neurobiology and the Assembly on Clinical Problems.