Clinical Trials Archives

UVa Health System, Pulmonary and Critical Care Department seeks healthy children, adolescents, and young adults ages 5 to 20, with snoring and possible sleep-related obstructive breathing disorders for a research study.

The purpose of this study is to find out if an experimental portable device, called SoundTrak, can collect data about your breathing at home while you sleep, and determine whether you stop breathing during sleep (called sleep apnea). This data from the SoundTrak would then be compared to the data collected during a standard overnight sleep study at the General Clinical Research Center (GCRC) Sleep Lab. Read the rest of this entry

UVa Health System, Department of Medicine, Pulmonary Division seeks healthy men, women, children and adolescents ages 5 to 65, with snoring and possible sleep-related obstructive breathing disorders for a research study.

The purpose of the study is to determine if an experimental device for sleep monitoring can accurately tell if you are awake or asleep and how well you are sleeping. The experimental device will be compared to a sleep study done using standard sleep monitoring equipment.
The study involves 1 outpatient consent and screening visit that will last about 1 hour, and 1 overnight stay at UVa Health Systems GCRC of about 16 hours for sleep monitoring.

§ Study-related screening visit and overnight sleep test (standard test to detect the presence of sleep apnea) provided free of charge.
§ Compensation for study completion is $ 125.00
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Cardiac Concepts Inc., a med-tech firm that’s remained largely quiet since raising $21 million in venture capital in 2008, has launched a clinical trial in Europe.

The Minnetonka-based firm has enrolled its first patient in the study, which will examine how its implantable device can help heart failure patients who suffer from sleep apnea. The company’s product, the RespiCardia System, is designed to treat central sleep apnea, where breathing is disrupted when muscles in the chest don’t work properly. The company will test its device on 40 patients.

Central sleep apnea is different from obstructive sleep apnea, a condition that causes throat muscles to contract. Twin Cities firms, including Apnex Medical Inc., are developing implantable devices to treat that condition.

Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced today enrollment of the first European patients in a Pilot Clinical Trial.

The purpose of the Pilot Study is to understand the respiratory and cardiac benefits of the RespiCardia(TM) System when treating a breathing disorder known as Central Sleep Apnea (CSA) in Heart Failure patients. Prof. Piotr Ponikowski, Principal Investigator of the Pilot Clinical Trial at The Medical University/4th Military Hospital in Wroclaw, Poland, commented that the system was successfully implanted in 2 male patients, ages 57 and 68 years with ischemic cardiomyopathy and symptoms of moderate heart failure. Despite optimal medical management, both experienced severe sleep breathing disorders. The trial is a 40 patient study being conducted in a number of centers worldwide. Implants are expected to begin in the United States in the coming months. Read the rest of this entry

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