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Could a small wire in the neck replace the CPAP mask?

NCT ID NCT06283030

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested whether a small electrode placed near the tongue nerve could be safely used in people with obstructive sleep apnea. 14 adults who could not use CPAP took part. The goal was simply to see if the nerve could be reached and stimulated, not yet to treat the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypoglossal nerve stimulation device
What this could lead to
If successful, this could lead to a less invasive implant for treating obstructive sleep apnea without a CPAP mask.
What could go wrong
This is a very early proof-of-concept study with only 14 people. It only tests if the nerve can be reached and stimulated safely, not whether it actually treats sleep apnea long-term.

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

Jan 2022

Finished

May 2023

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

21 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 an OSA diagnostic or surgical procedure. * Subject suffers with moderate to severe OSA based on history and a physical exam. * Subject has failed, refused or has not tolerated CPAP treatment. * Subject is willing and capable of providing informed consent. * Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space. --Subject is willing to participate in the designated follow-up visits. * Subject must be in good general health. * Subject 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. * Subject must be minimum of 21 years and maximum 80 years of age. * Subject's Hypoglossal Nerve must be able to be visualized using ultrasound Exclusion Criteria: * Subject has Body Mass Index above 38kg/m2. * Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat. * Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study. * Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.

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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

  • Vanderbilt Bill Wilkerson Centre

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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