Sleepers, Awake: You’re At Risk

Obstructive sleep apnea, OSA, is much more than a nuisance and a disturber of sleep. It is the most common type of sleep disordered breathing, affecting 38 million patients in the United States – but only about 20 percent of them are being treated for it. Approximately 24 percent of adult men and 9 percent of adult women in the United States are affected.

"It really is creating a physical problem that leads to a number of co-morbidities," said Jasper Benke, vice president of regulatory affairs and quality assurance in San Diego, Calif., for ImThera Medical Inc. The privately funded company makes a surgically implanted neurostimulation device that stimulates the hypoglossal nerve to control certain tongue muscles, preventing a sleeper’s tongue from collapsing into the upper airway. The device, not yet sold in the United States, is marketed as a safe, effective alternative for OSA patients who will not or cannot use CPAP – continuous positive airway pressure – therapy.

Positive airway pressure is the gold standard in OSA treatment, and CPAP is a subset of it. CPAP forces air into the respiratory tract to keep the airway open. If patients comply, the progression of OSA will be halted. But the precise fit of CPAP devices is difficult; the machines are loud and difficult for the patient, Benke said. That's why ImThera and many other companies are trying passive ways to affect the airway, he said. Implanted devices also make tracking patients’ compliance much easier, he added.

"What we're finding is that patients with sleep apnea are two or three times more likely to suffer from cardiovascular disease, congestive heart failure, stroke – the standard causes of cardiovascular death," Benke explained. He said OSA leads to an increase in diabetes and a sevenfold increase in traffic accidents, costing $11 billion per year.

"That's a pretty alarming number," Benke said. "We know that the trucking and transportation industry is aware [of OSA]. Whenever people stay up at night or have extreme hours of work, they are aware."

The ImThera device will be sold in Europe within the next four months, with trials in the United States taking place within the next six months, he said, adding that ImThera will establish four to six centers in the United States soon to do the implants.

Obstructive sleep apnea results from the collapse of the person's airway, so the person stops breathing, during sleep. This causes non-restful sleep and physiological problems, mainly hypertension-related problems. "We're just starting to understand that these problems that people are going to the doctor for -– they're potentially treating the symptoms and not the cause of the disease," said Benke.

The company's device is a small battery implanted in the chest with a wire attached to the nerve. The patient has a remote control and turns on the device just before going to sleep. People who use it feel better, and their compliance is good, said Benke, citing a 50-70 percent improvement in the apnea-hypopnea index (AHI), which is a measure of apnea severity.

National Sleep Awareness Week takes place March 7-13, and the National Sleep Foundation's Sleep Health & Safety conference will take place March 17-18 at the JW Marriott in Washington, D.C. The conference includes a Health Care Professional track and a Public Health and Safety Track with "Extended Duration Work Shifts and Long Work Weeks" as the theme. Confirmed speakers during the event include representatives from OSHA, the Nuclear Regulatory Commission, the U.S. Chemical Safety & Hazard Investigation Board, the National Transportation Safety Board, and the Walter Reed Army Institute of Research.

Posted by Jerry Laws on Mar 07, 2011