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Tiny electrode zaps tongue nerve to fight sleep apnea

NCT ID NCT06283017

Knowledge-focused Sponsor: Invicta Medical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested whether a small electrode placed near the nerve that controls tongue movement could help people with obstructive sleep apnea. Fourteen adults who already needed surgery took part. The main goal was to see if the approach was safe and could make the tongue stick out, which might keep the airway open during sleep.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome sleep disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep apnea Sleep apnea syndromes Sleep apnea, obstructive Sleep disorder

Contacts and locations

Locations

  • Adelaide Institute for Sleep Health, Flinders University

    Adelaide, South Australia, 5042, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.