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Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study) (Lingual)

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transvenous hypoglossal nerve stimulation
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Neural Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grantham Hospital
  • Prince of Wales Hospital
  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transvenous hypoglossal nerve stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2017
Last Updated
August 16, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03210142
Brief Title
Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)
Acronym
Lingual
Official Title
Minimally Invasive Hypoglossal Nerve Stimulation Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep Apnea, Neural Stimulation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transvenous hypoglossal nerve stimulation
Arm Type
Experimental
Arm Description
Transvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure.
Intervention Type
Procedure
Intervention Name(s)
Transvenous hypoglossal nerve stimulation
Intervention Description
Transvenous hypoglossal nerve stimulation to open upper airway.
Primary Outcome Measure Information:
Title
Effect of transvenous hypoglossal nerve stimulation on tongue position
Description
Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.
Time Frame
During study procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

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