Obstructive sleep apnea (OSA) is a common disease affecting 18 million Americans that can be effectively treated with the first-line therapy, continuous positive airway pressure (CPAP). Yet according to studies, including a randomized controlled trial of 1,500 participants and a Cleveland Clinic study of 648 patients diagnosed with OSA, less than half of people with OSA are compliant with CPAP therapy.
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This has made OSA a disease in need of a new treatment option. If untreated, patients with moderate to severe OSA are “chronically sleep deprived, fall asleep in social situations, have cognitive impairment and put a tremendous burden on their heart every night,” says Douglas Trask, MD, PhD, an otolaryngologist at Cleveland Clinic’s Head & Neck Institute.
In April 2014, a new treatment for OSA, Inspire® Upper Airway Stimulation, was approved by the FDA. Inspire therapy is the first implantable neurostimulation technology designed to address airway obstructions. “Inspire therapy offers a new and different approach to this problem by working with the natural physiology of the patient,” says Dr. Trask.
How it works
The Inspire therapy system consists of three implantable components: a programmable neurostimulator, a stimulation lead that delivers mild stimulation to the hypoglossal nerve, and a pressure-sensing lead that detects respiration. Controlled by a handheld device, the system senses breathing patterns and prompts the hypoglossal nerve to move the tongue forward so that the patient’s airway stays open when it needs to.
“Since there are so many people who aren’t using CPAP, we are undertreating OSA patients. Inspire therapy is a very exciting breakthrough resulting from a lot of scientific work that provides another tool to treat our patients,” says Cleveland Clinic otolaryngologist Alan Kominsky, MD.
Implanting the system
The Inspire system is implanted during an outpatient procedure under general anesthesia. Three incisions — below the jaw, under the collarbone and under the pectoralis muscle — are made to implant the three components. Unlike traditional surgical options, the Inspire therapy procedure does not involve cutting or rearranging the tissues in the throat or jaw.
“Many patients don’t choose traditional surgery because of the pain and time of recovery involved. This is a whole different class of surgery. But they aren’t mutually exclusive; traditional surgery will still be indicated for certain patients, such as those with large tonsils obstructing the airway,” says Dr. Kominsky.
Patient selection and follow-up
Inspire therapy is indicated for patients who are:
- 22 and older
- Have CPAP intolerance
- Have a body mass index of 32 or less and moderate to severe OSA with an index of 20 to 65
- Apneas must be mostly obstructive
“Most people with OSA have multilevel obstruction: in the nose or behind the palate or tongue. Inspire therapy was originally thought to mostly treat the back of the tongue, but in practice it provides retropalatal improvement as well,” says Dr. Trask. Patients undergo a sleep study before the procedure to ensure they qualify and after to titrate the device so that it provides stimulation that opens the airway without waking the patient.
Clinical data confirm efficacy
The results of a major trial of Inspire therapy, Stimulation Therapy for Apnea Reduction (STAR), were published January 2014 in the New England Journal of Medicine, which paved the way for the device’s approval.
In the prospective, 22-center trial, 126 patients with moderate to severe OSA who were implanted with the Inspire system were followed for 12 months. Patients showed a significant decrease in the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI): AHI scores decreased by 68 percent and ODI by 70 percent. Quality of life measures also improved: Epworth Sleepiness Scale scores decreased and Functional Outcomes of Sleep Questionnaire scores increased.
The device had a less than 1 percent serious adverse event rate; minor side effects such as tingling in the tongue can be easily addressed.
A multidisciplinary approach
At Cleveland Clinic’s Head & Neck Institute, a multidisciplinary team of sleep neurologists, otolaryngologists, pulmonologists and sleep medicine physicians work collaboratively to select appropriate patients for Inspire therapy and provide comprehensive care from preparation through long-term follow-up.
Drs. Kominsky and Trask are among a select group of physicians nationwide who are board-certified in otolaryngology and sleep medicine. “We have a group of physicians who each bring a unique perspective to the problem and are looking for the best treatment option for the patient,” says Dr. Trask.