ClinicalTrials.gg
Not yet recruitingNCT07711678Updated Jul 17, 2026

Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

An interventional study of Implantable Hypoglossal Nerve Stimulation System in Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea and Respiration Disorders, sponsored by Beijing Pins Medical Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Beijing Pins Medical Co., Ltd · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 108 studies in Sleep Apnea, Obstructive with a site in China — 48 open to participants now, 50 under way, 10 of them phase 3. Sleep Apnea, Obstructive · China.

Planned enrollment
59th of 60
10 · median 140
Started
2026
with 14 others
No phase
42 of 108
11 open now
Primary completion
2027-02
later than 24 of 49 live
Registered
102nd of 108
by date

Among the 108 studies in Sleep Apnea, Obstructive with a site in China, this one is the 59th largest by planned enrollment of the 60 interventional ones that give a count, is one of 15 that started in 2026, is one of 42 with no phase, reaches primary completion later than 24 of the 49 other live ones, and was the 102nd registered.

Sleep Apnea, Obstructive

2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Open to participants now

48 of the 108 studies in Sleep Apnea, Obstructive with a site in China are open now. Recruiting first, the newest first:

43 more — sign in →

All 48 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 108 studies in Sleep Apnea, Obstructive with a site in China, or all of them as a file.
02

Study summary

The objective of this study is to evaluate the safety and preliminary effectiveness of an implantable hypoglossal nerve stimulation system for moderate-to-severe obstructive sleep apnea (OSA).

03

Conditions studied

  • Obstructive Sleep Apnea (OSA)
  • Syndrome, Obstructive Sleep Apnea
  • Respiration Disorders
  • Sleep Apnea Syndrome, Obstructive

Keywords

  • Hypoglossal nerve stimulation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. ≤40 kg/m².
  5. Able to communicate with the investigator, understand the study requirements, and provide written .
  6. Willing and able to comply with study procedures and complete postoperative follow-up visits.

Exclusion criteria

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 dysphagia.
  4. Severe cardiopulmonary disease, including but not limited to , 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 .
  9. Presence of an implanted active medical device that may interact with the 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Implantable Hypoglossal Nerve Stimulation

    Device: Implantable Hypoglossal Nerve Stimulation System

Interventions

  • DeviceImplantable Hypoglossal Nerve Stimulation System

    The investigational device is an implantable hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.

06

What researchers measure

Primary outcomes

  1. Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3)

    Time frame: 3 months after therapy activation

Secondary outcomes

  1. Response Based on the Oxygen Desaturation Index With a ≥3% Oxygen Desaturation Criterion (ODI3)

    Time frame: 3 months after therapy activation

  2. Change in Percentage of Total Sleep Time With Oxygen Saturation Below 90%

    Time frame: 3 months after therapy activation

  3. Change in Epworth Sleepiness Scale (ESS) Score

    Time frame: 3 months after therapy activation

  4. Change in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) Total Score

    Time frame: 3 months after therapy activation

  5. Participant Investigator Equipment Satisfaction Evaluation

    Time frame: 3 months after therapy activation

  6. Investigator Equipment Satisfaction Evaluation

    Time frame: 3 months after therapy activation

  7. Malfunction Rates of External Devices and Accessories

    Time frame: 3 months after therapy activation

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Feb 2027, 7 months later.

Of 116 industry-sponsored interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 7 months is below that.

Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2026
First posted
Jul 17, 2026
StartEst.
Jul 15, 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
Feb 28, 2027
Last update
Jul 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07711678
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Jul 15, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Jianguang Sun
Contact
sunjianguang@pinsmedical.com
010-60736388

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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