A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive; Down Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is
      associated with adverse behavior and quality of life, as well as long term cardiopulmonary
      system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder,
      with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a
      higher incidence of OSA than the general pediatric population, with rates of 30-60%,
      resulting in increased morbidity and decreased quality of life for affected individuals. In
      children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and
      adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A
      for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns
      requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent
      obstruction is attributed to anatomic and physiologic differences in this population,
      including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil
      hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway
      Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved
      under P130008 for the treatment of obstructive sleep apnea, which has already been approved
      for use in adults with OSA, can be safely implanted and used in adolescents and young adults
      with Down Syndrome.
    

Detailed description: 
      The study will be a multi-center, prospective, single-arm study conducted under a common
      implant and follow-up protocol. Twenty-one adolescents and young adults (10-21 years of age)
      with Down Syndrome with moderate to severe obstructive sleep apnea after adenotonsillectomy
      will be identified through a Multi-Disciplinary clinic for patients with Trisomy 21 at each
      of our participating sites Patients and their parents will be screened by a senior
      pulmonologist and pediatrician for medical clearance and willingness to participate. Subjects
      will then undergo preoperative evaluation with an in-lab polysomnogram (PSG), evaluation by a
      pediatric otolaryngology surgeon, and drug induced sleep endoscopy (DISE) to ensure all
      inclusion and exclusion criteria are met. Subjects meeting eligibility criteria will then be
      implanted with the Inspire® Upper Airway Simulation System, Model 3024 IPG, and any
      subsequent iteration thereof that are approved under P130008 for the treatment of obstructive
      sleep apnea, a hypoglossal nerve stimulator, after informed consent. Surgery will be
      performed by senior pediatric otolaryngologists who have completed a training program for the
      Inspire® system. Subjects will then adhere to a follow-up schedule. The device will be
      activated and settings titrated during an in-lab sleep study 1 month postoperatively. Quality
      of life surveys and device interrogation will be conducted at timed intervals. Subjects will
      then undergo in-lab polysomnography at 2 months, 6 months, and 12-months, then on an annual
      basis, and the device titrated as needed. All personnel adjusting device parameters will be
      trained in programming the Inspire® system. For this pilot study, we will evaluate safety and
      efficacy over the first year after device implantation.
    

Intervention name(s): Inspire® Upper Airway Simulation System (Model 3028 IPG )
Intervention type(s): Device
Intervention description(s): Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.
Other intervention name(s): hypoglossal nerve stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment