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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210142
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Procedure: Transvenous hypoglossal nerve stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Minimally Invasive Hypoglossal Nerve Stimulation Study
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Transvenous hypoglossal nerve stimulation
Transvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure.
Procedure: Transvenous hypoglossal nerve stimulation
Transvenous hypoglossal nerve stimulation to open upper airway.




Primary Outcome Measures :
  1. Effect of transvenous hypoglossal nerve stimulation on tongue position [ Time Frame: During study procedure ]
    Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210142


Locations
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Hong Kong
Grantham Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03210142    
Other Study ID Numbers: MDT16057
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Sleep Apnea, Neural Stimulation
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases