Sleep apnea is a condition in which people have one or more pauses in breathing or shallow breaths while they sleep. Breathing pauses can last from a few seconds to minutes. The pause can occur 5 to 30 times or more in an hour. The interesting part is most people who have sleep apnea don’t know, if they have it because it only occurs during sleep. It is often goes undiagnosed. Physician can’t diagnose the condition during routine office visits and there is no blood test that detects the condition.
According to the National Institutes of Health (NIH), about 12 million Americans suffer from sleep apnea. The most common type of sleep apnea (that affects almost 90% of people) is Obstructive Sleep Apnea (OSA). Current treatments for OSA include weight loss, oral appliances, surgery and continuous positive airway pressure therapy (CPAP). CPAP machine with the right CPAP masks is one of the most effective treatments for OSA. However, many OSA sufferers could not continue CPAP therapy as sometimes masks doesn’t fit properly or other reasons, such as a feeling of claustrophobia.
Recently, Inspire Medical Systems has developed an implanted device, Upper Airway Stimulation (UAS) Therapy, for the treatment of sleep apnea. The device consists of a pulmonary pressure sensor implanted in the chest, a pulse generator that looks very similar to a pacemaker, and a lead that is implanted close to the hypoglossal nerve. The device stimulates the nerves in the tongue, opening the airways during sleep for better breathing. Earlier clinical study has shown positive results in apnea-hypopnea index (AHI) used in selected patients.
Currently, the system is an investigational device, and its use is limited to investigational purposes only. The company is planning to start its clinical trial with 100 sleep apnea patients in January to evaluate the potential of device therapy. Sleep apnea patients who are interested to be a part of the trial can participate in a survey on the Inspire Medical Systems website to see if they qualify for the trial. Besides, Inspire Medical Systems two other companies have also announced small scale testing.
Sleep apnea may seem like a simple problem of interruption of sleep, but can lead to fatal health conditions. It can trigger other diseases like hypertension and increase risk of car accidents by seven folds. UAS type devices do show promise in treating patients suffering from OSA while maintaining the quality of life unlike the current options like CPAP. We look forward for this technology to get approval from FDA.