Lacy Downer had exhausted all of her options.
For more than a decade, since her youngest son was diagnosed with sleep apnea, the family endured sleepless nights.
Until now.
In March 2023, then 14-year-old Jude Downer became one of the first patients at Monroe Carell Jr. Children’s Hospital at Vanderbilt to receive an implantable device designed to aid sleep.
Called Inspire, it is the first FDA-approved obstructive sleep apnea therapy that works inside the body. The device, implanted beneath the collarbone, delivers pulses to airway muscles (through hypoglossal nerves) to keep the throat open for better breathing and more sound sleep.
While sleeping, airway muscles and the tongue relax, and for some, the tongue relaxes into a position that blocks the airway. When the airway is blocked, less oxygen goes to the brain, triggering a person to wake up to take a breath.
Monroe Carell is the only location in Tennessee and one of the busiest sites in the Southeast performing this treatment for pediatric patients with Down syndrome and severe sleep apnea. The treatment received approval for this use in 2023.
“We were at the ‘What are we going to do now?’ stage,” recalled Downer. “We had literally done everything in an effort to assist with his sleep apnea,” she said of her son, who had tonsil and adenoid removal, tongue reduction surgery, lingual tonsillectomy (twice) and used a CPAP (continuous positive airway pressure) machine.
“With all of the treatments, we had periods of improvement but always ended back with sleep problems and continued apnea. He is a wild sleeper, so keeping the CPAP mask on was a challenge.
“Before he got Inspire, he would wake up every single morning saying he was so, so tired. He even had a sleep break scheduled into his school day, and he had dark circles under his eyes,” said Downer. “It was also impacting my sleep and the whole dynamic of the house.”
Downer admitted Inspire has been a game changer for her now 16-year-old son and their family.
According to Christopher Wootten, MD, professor of Otolaryngology – Head and Neck Surgery at Monroe Carell, Down syndrome patients often have a relatively large tongue, compared to the size of their head and facial structures, making the tongue base a challenge for airway obstruction leading to chronic sleep apnea.
While traditional interventions can help, oftentimes they are not a long-term fix for this population of patients.
“One of the reasons I am excited about this device … Instead of doing operations that continue to excise and reduce tissue in the nose, throat and voice box that can be obstructing the airway, this device uses nerve stimulation of the tongue base to open up the airway,” said Wootten.
“Every time a patient takes a breath during sleep, the sensor in the chest detects it and sends a signal to the tongue to protrude in rhythm with the breaths, which opens up the airspace. This technology is a major off ramp.
“Throat-based surgeries are our first line, but continually doing those interventions can have a finite benefit. Inspire is a long-term and durable solution, and it’s much easier to be compliant. It is simple to turn on and off using a remote.”
Jude’s Inspire device took some adjustments to ensure he was at the optimal therapy level for him. His team continues to work with him to make adjustments to the strength of pulses needed to provide an open airway without waking Jude up, said his mom.
“It was a slower process from getting the device turned on and turning it up incrementally, but it’s been worth the wait,” said Downer. “This has been the longest lasting surgical intervention with the best success. It allows him to be independent, which is what he wants.
“It’s amazing technology,” she added.
Inspire requires that children with Down syndrome meet specific criteria to be considered for the device including being 13 years old or older, having a severe obstructive sleep apnea diagnosis, having the inability to tolerate or successfully use CPAP, and having sleep apnea that was not cured by adenotonsillectomy.
Wootten said his team has performed five implants since 2023 with six more scheduled over the next six months.
