Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Procedure: Transvenous hypoglossal nerve stimulation

• Registration Number: NCT03210142
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-14
• Study Start: 2017-06-23
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Primary Completion: 2018-02-08
• Study Completion: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Subject is at least 18 years old
• Subject is undergoing a standard new device implant, cardiac catheterization involving right heart catheterization and/or EP procedures
• Subject is able and willing to give informed consent

Exclusion Criteria

• Subject is unable or unwilling to participate with study procedures
• Subject is pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment)
• Subject is known to be allergic to radio opaque dye
• Subject has a body mass index (BMI) >40 kg/m2
• Subject has had prior neck surgery that may interfere with vascular access to the lingual vein
• Subject has had prior surgery of the oral cavity that may interfere with tongue or soft palate movement
• Subject has a significant upper airway-related anatomic anomaly
• Subject is enrolled in a concurrent study that may confound the results of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvenous hypoglossal nerve stimulation	Transvenous hypoglossal nerve stimulation	Transvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure.

Primary Outcome Measures

Name	Time	Method
Effect of transvenous hypoglossal nerve stimulation on tongue position	During study procedure	Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.

Trial Locations

Locations (3)

Grantham Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong