Could a tiny nerve implant silence sleep apnea without a mask?
NCT ID NCT07711678
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This pilot study tests an implantable device that stimulates the hypoglossal nerve to keep the airway open during sleep. It is for adults with moderate-to-severe obstructive sleep apnea who have tried but cannot tolerate a CPAP machine. The goal is to see if the device is safe and can reduce breathing pauses and improve 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
- an implantable device that electrically stimulates the hypoglossal nerve to prevent airway collapse during sleep
- What this could lead to
- If it works, this could offer a new treatment option for people with obstructive sleep apnea who cannot use a CPAP machine.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply to everyone. The device requires surgery, and long-term safety and effectiveness are not yet known.
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 1. Age 18 years or older, regardless of sex. 2. Moderate-to-severe obstructive sleep apnea confirmed by polysomnography, with an apnea-hypopnea index of 15 to 100 events per hour. 3. Prior failure of, intolerance to, or unwillingness to continue positive airway pressure therapy. 4. Body mass index ≤40 kg/m². 5. Able to communicate with the investigator, understand the study requirements, and provide written informed consent. 6. Willing and able to comply with study procedures and complete postoperative follow-up visits. Exclusion Criteria 1. Central and mixed apnea and hypopnea events account for more than 25% of the total apnea-hypopnea index. 2. Presence of obvious fixed upper airway obstruction or obstructive upper airway lesions, including but not limited to tumors or masses, polyps, scar stenosis, or severe nasal septal deviation involving the nasal cavity, nasopharynx, oropharynx, hypopharynx, or larynx, which, in the investigator's judgment, may affect device implantation, treatment effect, or evaluation of the primary effectiveness endpoint. 3. Abnormal hypoglossal nerve function; neurological or neuromuscular disease that may affect upper airway neuromuscular control or tongue movement; or clinically significant dysphagia. 4. Severe cardiopulmonary disease, including but not limited to chronic obstructive pulmonary disease, severe asthma, chronic respiratory failure, myocardial infarction, or severe arrhythmia. 5. Any disease or condition that precludes general anesthesia or may interfere with implantation of the hypoglossal nerve stimulation system. 6. Pregnant or lactating women, or women planning pregnancy during the study period. 7. Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study. 8. Participation in another clinical trial within 4 weeks before signing informed consent. 9. Presence of an implanted active medical device that may interact with the investigational hypoglossal nerve stimulation system, affect treatment effectiveness, or compromise participant safety. 10. Unable or unwilling to discontinue other obstructive sleep apnea-related treatments during the study, except for the investigational hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
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Other studies related to the condition(s) this trial covers.
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