Tampa General Hospital’s (TGH) Ear, Nose & Throat (ENT) Institute completed Florida’s first Inspire implant surgery on a pediatric patient diagnosed with Down syndrome and sleep apnea, according to a release from the hospital.

The surgery was performed by University of South Florida Health otolaryngologist Abhay Sharma, MD, assistant professor and director of the division of interventional sleep surgery at the USF Health Morsani College of Medicine. He was assisted by Tapan Padhya, MD, chief of the TGH ENT Institute, professor, chair and chief in the division of head and neck oncology, professor and chair of the department of otolaryngology-head and neck surgery at USF Health Morsani College of Medicine, and founder and co-director of the USF Health ENT Sleep and Snoring Center. 

Both are full-time academic faculty members in the department of otolaryngology-head and neck surgery at USF Health Morsani College of Medicine.

More than half of children with the genetic disorder Down syndrome have sleep apnea,” Padhya says in a release. “This implantable device marks a substantial improvement in obstructive sleep apnea care for preteens and teenagers with Down syndrome and provides greater peace of mind for their parents.”

Sharma adds in the release, “The Inspire implant surgery is minimally invasive, and the recovery time for the patient is minimal. Before this procedure, traditional treatments for Down syndrome patients with obstructive sleep apnea could include major facial surgery to separate and move a patient’s upper and lower jaws. The implantable device offers a gentler treatment for these young patients.”

The Inspire device is the only implant the US Food and Drug Administration has approved to treat sleep apnea, and it is one of the few alternatives to using a continuous positive airway pressure machine. 

The implant is similar to a cardiac pacemaker and is placed under the collarbone during the two- to three-hour surgery. After that, it is operated via a remote control. Electric connectors beneath the skin deliver a small electrical stimulus to the base of the tongue when a patient takes a breath, gently pushing the tongue out to aid airflow. The open airway eliminates the struggle to breathe which characterizes sleep apnea, and patients can experience more restful sleep. 

To qualify for the pediatric procedure, patients must have Down syndrome, be between 12 and 18 years of age, have moderate to severe sleep apnea, and be intolerant of a CPAP device. 

While trials have suggested that a weight below the 95th percentile is safest for children undergoing this procedure, there is no specific weight criteria for children as there is for adults.

The recovery time for an Inspire implant surgery is typically minimal. Following the pediatric procedure at the academic health system, the patient who was 16 years of age at the time of the surgery, remained one night at the TGH Children’s Hospital.

According to the National Institutes of Health, 55% to 97% of people with Down syndrome have obstructive sleep apnea. In addition to facial structure differences, excessive weight in patients with Down syndrome often contributes to sleep apnea. It is difficult for young patients with Down syndrome to lose weight, and typically these patients can’t tolerate CPAP machines due to discomfort and an inability to understand why the machine is necessary and how it works. The implantable device makes it easier for caregivers of patients with Down syndrome to support their needs and improve their quality of life.

“As the indications continue to evolve, we will likely see even younger kids who are having severe sleep apnea who can get this therapy,” Sharma says in the release. “We are optimistic that, with the right protocols, this could be a game-changer for pediatric sleep apnea.”