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Nerve zap in the neck could replace CPAP for sleep apnea

NCT ID NCT04950894

Disease control Sponsor: LivaNova 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial tests a device called the aura6000 that stimulates a nerve in the neck to keep the airway open during sleep. It is for adults with moderate to severe obstructive sleep apnea who cannot or will not use a CPAP machine. Participants are randomly assigned to have the device turned on or off for six months to see if it reduces breathing pauses and improves sleep quality.

What this could mean

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

Active substance
a device that stimulates the hypoglossal nerve (aura6000 System)
What this could lead to
If successful, this could offer a new treatment option for people with moderate to severe sleep apnea who cannot tolerate CPAP machines.
What could go wrong
This is an early-stage trial with a moderate number of participants, so results may not apply to everyone. The device requires surgery and carries risks such as infection or device-related complications.

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

107 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2025

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

22 years and older

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.

Abbreviated: Additional criteria may apply: Inclusion Criteria: * Diagnosis of moderate to severe OSA * Declines to use or does not tolerate PAP therapy Exclusion Criteria: * Respiratory, cardiac, renal disease or other co-morbid conditions * BMI \> 35 kg/m2 * Specific PSG criteria outlined in the protocol

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Conditions

The condition(s) this trial relates to.

Apnea obstructive sleep apnea syndrome sleep apnea syndrome Snoring

As listed by the trial registrant

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

Apnea Apnea+hypopnea Apnea, obstructive Apnea, obstructive sleep Hypopnea, sleep Obstructive sleep apnea OSA

Contacts and locations

Locations

  • Advanced Ent Associates

    Atlanta, Georgia, 30342, United States

  • Alivation Research Llc

    Lincoln, Nebraska, 68526, United States

  • Bogan Sleep Consultants, Llc

    Columbia, South Carolina, 29201, United States

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Lankenau Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Morton Plant Mease Health Care

    Safety Harbor, Florida, 34695, United States

  • Norton Healthcare

    Louisville, Kentucky, 40218, United States

  • Paul Schalch Lepe, Md/Silenso Clinic

    San Diego, California, 92130, United States

  • Penn State Health

    Hershey, Pennsylvania, 17033, United States

  • Raleigh Neurology Associates, Pa

    Raleigh, North Carolina, 27607, United States

  • Sacramento Ent

    Roseville, California, 95661, United States

  • Sleep Medicine Specialists of South Florida

    Miami, Florida, 33126, United States

  • University of Alabama At Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Weill Cornell Medical College

    New York, New York, 10024, United States

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