CompletedNot Applicable

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

Australia14 participantsStarted 2022-04-06

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Target identification and access outcomes

Timeframe: Day 0

Tongue protrusion outcomes

Timeframe: Day 0

Characterization of lead placement outcomes

Timeframe: Day 0

Lead placement and removal outcomes

Timeframe: Day 0

Safety outcomes

Timeframe: Day 30

Trial details

NCT IDNCT06283017

SponsorInvicta Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-27

View on ClinicalTrials.gov More Sleep Apnea trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.