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Shock therapy for snorers? new device zaps airway muscles to stop sleep apnea

NCT ID NCT04607343

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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a device that delivers mild electrical stimulation to muscles in the throat to strengthen them and keep the airway open during sleep. It includes 5 healthy volunteers and 12 people with mild to severe obstructive sleep apnea. The goal is to see if using the device twice daily for eight weeks reduces breathing pauses and improves oxygen levels.

What this could mean

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

Active substance
transcutaneous electrical stimulation device
What this could lead to
If it works, this could offer a non-invasive treatment option for obstructive sleep apnea by strengthening airway muscles.
What could go wrong
This is a very small, early-stage trial (17 participants) that is currently suspended. The device may not effectively reduce apnea events or may cause discomfort.

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

About 17 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients over 18 years of age with confirmed OSA (four with mild OSA, four with moderate OSA and four with severe OSA) who sign their informed consent to participate in the study. Exclusion Criteria: * Pregnancy * Basal polysomnography that does not meet validity criteria to be interpreted. * Anticoagulation (although not a contraindication for laryngopharyngeal sensory endoscopic testing, anticoagulation is an exclusion criterion for this study to maintain the lowest level of risk). * Haemorrhagic diathesis (to avoid risk of severe epistaxis during nasal endoscopy). * Glasgow scale less than 15 (to avoid confusion with sensory or motor laryngopharyngeal involvement due to neurological disease that compromises the state of consciousness). * Basal oxygen saturation by awake pulse oximetry below 88%. * Patients with more than 5% of the total apnoea events being of central origin. (to avoid including patients with central sleep apnoea in whom laryngopharyngeal electrostimulation would have no effect). * Inflammatory or infectious lesions on the face or neck * Skin hypersensitivity * Anaesthetic areas, burns, bruises or recent wounds in the area of electrical stimulation * Cardiac pacemakers or other telemetry-controlled devices, * History of maxillofacial or pharyngeal surgery. * Active cancer * Tumours of the laryngopharyngeal tract. * Significant mental and/or behavioural conditions or inability of the patient to cooperate during the examination/intervention. * Epilepsy * Central Nervous System (CNS) surgery in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Brain trauma in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Neurological sequelae of any cause compromising the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Underlying neuromuscular diseases affecting the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal involvement due to neuromuscular disease). * Chronic use of systemic corticosteroids at doses greater than or equal to 20 mg daily of prednisone or equivalent (to avoid confusion with corticosteroid myopathy that compromises the laryngopharyngeal region). * Bone prostheses or osteosynthesis (in polarized currents there is danger of chemical burn and bone resorption) * Acute febrile processes * Chronic decompensated diseases * Diseases in terminal states * Refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fundacion Neumologica Colombiana

    Bogotá, Bogota D.C., 11111, Colombia

  • Universidad de La Sabana

    Chía, Cundinamarca, Colombia

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