A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
NCT: NCT06627127 · COMPLETED
Brief Summary
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
Frequently Asked Questions
What is A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea?
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea is a clinical trial registered under NCT06627127. Current status: COMPLETED.
What is the status of NCT06627127?
The current status of NCT06627127 (A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea) is: COMPLETED.
When did A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea start?
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea started on 2023-11-06.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.