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New implant could help sleep apnea patients ditch the CPAP mask

NCT ID NCT06540716

Disease control Sponsor: Inspire Medical Systems, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the Inspire system, a device that stimulates a nerve in the neck to keep the airway open during sleep. It involved 44 adults in Singapore with moderate-to-severe obstructive sleep apnea who could not use CPAP. The main goal was to confirm the device works properly and reduces breathing pauses and daytime sleepiness.

What this could mean

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

Active substance
Inspire hypoglossal nerve stimulation device
What this could lead to
If confirmed, this device could offer a long-term alternative to CPAP for people with moderate-to-severe sleep apnea who cannot tolerate CPAP.
What could go wrong
This is a small, completed device performance study with no control group. Results may not apply to all patients, and the device requires surgery and ongoing use.

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

44 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 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

21 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.

Main Inclusion Criteria: * Diagnosis of moderate to severe OSA (AHI 15-65) * Failure of, or intolerance to CPAP Main Exclusion Criteria: * Central + mixed apneas \> 25% of total AHI * Presence of complete concentric collapse (CCC) * Compromised neurological control of the upper airway. Other eligibility criteria may apply.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea OSA Sleep apnea

Contacts and locations

Locations

  • National University Hospital

    Singapore, Singapore

  • Singapore General Hospital

    Singapore, Singapore

More trials for these conditions

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