Clinical trial NCT03210142: Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)
Official title: Minimally Invasive Hypoglossal Nerve Stimulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea, Neural Stimulation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of transvenous hypoglossal nerve stimulation on tongue position
timeFrame: During study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: