Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)
Lingual
1 other identifier
interventional
23
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedAugust 17, 2018
August 1, 2018
8 months
June 14, 2017
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Transvenous hypoglossal nerve stimulation
EXPERIMENTALTransvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure.
Interventions
Transvenous hypoglossal nerve stimulation to open upper airway.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Grantham Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
July 6, 2017
Study Start
June 23, 2017
Primary Completion
February 8, 2018
Study Completion
July 31, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share