- ClinicalTrials.gov ID: NCT04801771
- Recruiting participants (Starts Jun. 1, 2021)
- Not accepting healthy volunteers
- UTSW Principal Investigator: RON BENSON MITCHELL
summary
This is a multicenter, prospective, single-arm study of an implantable device for the treatment of obstructive sleep apnea in patients with Down syndrome and previous treatment of adenotonsillectomy. Subjects aged 10x21 with Down syndrome and Obstructive Sleep Apnea with previous treatment of adenotonsillectomy.
objective
2.1 Primary Objectives 1. Evaluate expressive language sampling (ELS) and neurocognitive testing (NCT) results prior to implant and 6 months following implant 2.2 Secondary Objectives 1. Evaluate adverse events (AEs) and serious adverse events (SAEs) that are related or possibly related to the device, surgery, or research testing procedures for 12 months postoperatively 2. Therapy efficacy measured by OSA-18 and ESS-CHAD prior to implant and 12 months following implant 3. Therapy efficacy measured by AHI prior to implant and 12 months following implant