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Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

NCT06283030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-03-07

No results posted yet for this study

Summary

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

Conditions

  • Sleep Apnea
  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Sleep Disorder

Interventions

DEVICE

Hypoglossal nerve stimulation

Device-mediated stimulation of the hypoglossal nerve

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Invicta Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-09-25
Completion
2023-09-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283030 on ClinicalTrials.gov