The Inspire® Study: Hypoglossal Nerve Stimulator for Down Patients
For qualifying adults with obstructive sleep apnea, the FDA-approved Inspire® hypoglossal nerve stimulator (HNS) is quickly becoming the treatment of choice. In a multicenter study, the Upper Airway Center at Cincinnati Children’s has joined forces with Mass Eye and Ear to research the possibility of extending the use of this new therapy to 10- to 21-year-old Down syndrome patients with sleep apnea persisting after tonsil and adenoidectomy (T&A). The goal is to gain FDA approval for all centers to offer this treatment to this population. HNS is highly effective and many patients find it much easier to tolerate than Continuous Positive Airway Pressure (CPAP) therapy.
The HNS is an implanted device intended to coordinate tongue movement with breathing. A main, pacemaker-like unit is surgically placed beneath the right clavicle. One lead goes to the chest wall, to register breathing motion. The other lead delivers a low pulse to the hypoglossal nerve, to keep the airway open for inspiration. A remote control unit turns the system on and off.
The device has rocketed in popularity among adults, with 100 centers – including the University of Cincinnati and the Veterans Administration Hospital – already averaging about 70 implants a month. Surgeons from Cincinnati Children’s have been implanting the device in adults to gain experience they will then apply on behalf of the pediatric population. In the near future, when they do begin offering the devices to 10- to 21-year-olds, there will likely be a lot of demand. The Upper Airway Center services over 600 patients, and 40 percent have Down syndrome.
To be considered for the HNS, a patient must meet certain criteria. The BMI must be below the 96th percentile or, if the patient is over 18 years old, the BMI must be at or below 32kg/m2. The candidate cannot require an MRI, as the current device cannot be used in an MRI. And the patient’s frequency of apnea/hypopnea per hour must be moderate to severe – between 10 and 50 events/hour.
Patients who do qualify stand to benefit significantly. In one case, after receiving the device, a 14-year-old in Massachusetts was able to have her tracheostomy removed. “We’re really excited to be able to offer this treatment option,” says Stacey Ishman, MD, MPH, surgical director of the Upper Airway Center, “especially for special needs children who have difficulty tolerating CPAP.” Providers at the center believe the HNS will prove to be a highly useful tool for our patient population.
Other Upper Airway Center Updates
To better meet the needs of our patients, we are increasing our clinic days each month from five to eight and adding a second location (Liberty).
This summer, we are adding two new ENT providers (David F. Smith, MD, PhD and Christine Heubi, MD) who specialize in sleep.
We are continuing our work to standardize care and improve outcomes, with organized, multidisciplinary clinic care and research into airway modification and new airway imaging methods.
