Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

Sleep Apnea, Obstructive Clinical Trial

— Lingual  

Official title:

Minimally Invasive Hypoglossal Nerve Stimulation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210142
• Other study ID #: MDT16057
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 31, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Transvenous hypoglossal nerve stimulation
Transvenous hypoglossal nerve stimulation to open upper airway.

Locations

Country	Name	City	State
Hong Kong	Grantham Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of transvenous hypoglossal nerve stimulation on tongue position	Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.	During study procedure