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Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea | Clinical Trials | Clareo Health

UNKNOWNNA

Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

NCT06283017•Invicta Medical Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be eligible for a diagnostic or surgical procedure and
•Suffers from OSA (apnea/hypopnea index \>10 event/h sleep) based on history and a physical exam.
•Is a surgical candidate.
•Is willing and capable of providing informed consent.
•Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
•Is willing to participate in the designated follow-up visits.
•Must be in good general health.
•Is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
•Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria

•Has Body Mass Index above 35 kg/m2.
•Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
•Has significant co-morbidities making them unable or inappropriate to participate in this POC study.

Locations (1)

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, Australia

Key Dates

Start Date

June 1, 2022

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

March 13, 2024

Enrollment

ACTUAL participants

Conditions

Sleep ApneaSleep Apnea, ObstructiveSleep DisorderSleep Apnea Syndromes

Interventions

Hypoglossal nerve stimulation

DEVICE

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGNA

Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922

Obstructive Sleep Apnea (OSA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

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