NCT03210142

Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

Minimally Invasive Hypoglossal Nerve Stimulation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.

Detailed description

The primary objective is to determine the effect of tHGNS on tongue position in the upper airway in subjects undergoing an EP, cardiac catheterization or device procedure. (Measured as changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces.) This will be an acute study lasting no more than 45 min during a standard new device implant, cardiac catheterization and/or EP procedure. The hypoglossal nerve will be stimulated from the lingual vein using various stimulation parameters. Tongue motion, upper airway opening or any side effects will be recorded. At the end of the test procedure all hardware - the catheters, lead and/or guide wire will be removed.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
PROCEDURE	Transvenous hypoglossal nerve stimulation	Transvenous hypoglossal nerve stimulation to open upper airway.

Timeline

• Start date: 2017-06-23
• Primary completion: 2018-02-08
• Completion: 2018-07-31
• First posted: 2017-07-06
• Last updated: 2018-08-17

Locations

3 sites across 1 country: Hong Kong