Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Transvenous hypoglossal nerve stimulation

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

Group Type EXPERIMENTAL

Transvenous hypoglossal nerve stimulation

Intervention Type PROCEDURE

Transvenous hypoglossal nerve stimulation to open upper airway.

Interventions

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Transvenous hypoglossal nerve stimulation

Transvenous hypoglossal nerve stimulation to open upper airway.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No