Obstructive Sleep Apnea (OSA)NCT07711678
Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
A study testing Implantable Hypoglossal Nerve Stimulation System in people with Obstructive Sleep Apnea (OSA) and Syndrome, Obstructive Sleep Apnea, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea, Respiration Disorders
- What is being tested?
- Implantable Hypoglossal Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, regardless of sex.
- Moderate-to-severe obstructive sleep apnea confirmed by polysomnography, with an apnea-hypopnea index of 15 to 100 events per hour.
- Prior failure of, intolerance to, or unwillingness to continue positive airway pressure therapy.
- Body mass index ≤40 kg/m².
- Able to communicate with the investigator, understand the study requirements, and provide written informed consent.
- Willing and able to comply with study procedures and complete postoperative follow-up visits.
Who cannot join
- Central and mixed apnea and hypopnea events account for more than 25% of the total apnea-hypopnea index.
- 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.
- Abnormal hypoglossal nerve function; neurological or neuromuscular disease that may affect upper airway neuromuscular control or tongue movement; or clinically significant dysphagia.
- Severe cardiopulmonary disease, including but not limited to chronic obstructive pulmonary disease, severe asthma, chronic respiratory failure, myocardial infarction, or severe arrhythmia.
- Any disease or condition that precludes general anesthesia or may interfere with implantation of the hypoglossal nerve stimulation system.
- Pregnant or lactating women, or women planning pregnancy during the study period.
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- Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
- Participation in another clinical trial within 4 weeks before signing informed consent.
- Presence of an implanted active medical device that may interact with the investigational hypoglossal nerve stimulation system, affect treatment effectiveness, or compromise participant safety.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Jingying Ye, +86-13701396970, yejingying@yeah.net
About this study
Official title: A Pilot Study of Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
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).
- Conditions
- Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea, Respiration Disorders, Sleep Apnea Syndrome, Obstructive
- Being tested
- Implantable Hypoglossal Nerve Stimulation System
- Keywords
- Hypoglossal nerve stimulation
- Medical subject headings
- Sleep Apnea, Obstructive, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Hypoglossal Nerve Stimulation SystemDevice
The investigational device is an implantable hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Hypoglossal Nerve Stimulation | Experimental | Not described Receives: Device: Implantable Hypoglossal Nerve Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3)
Measured: 3 months after therapy activation
Secondary outcomes (7)
Response Based on the Oxygen Desaturation Index With a ≥3% Oxygen Desaturation Criterion (ODI3)
Measured: 3 months after therapy activation
Change in Percentage of Total Sleep Time With Oxygen Saturation Below 90%
Measured: 3 months after therapy activation
Change in Epworth Sleepiness Scale (ESS) Score
Measured: 3 months after therapy activation
Change in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) Total Score
Measured: 3 months after therapy activation
Participant Investigator Equipment Satisfaction Evaluation
Measured: 3 months after therapy activation
Investigator Equipment Satisfaction Evaluation
Measured: 3 months after therapy activation
Malfunction Rates of External Devices and Accessories
Measured: 3 months after therapy activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711678
- Sponsor's protocol ID
- PNS6101&PINS-C2-01-53
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07711678
- Acronym / sponsor ID
- PNS6101&PINS-C2-01-53
- Conditions
- Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea, Respiration Disorders, Sleep Apnea Syndrome, Obstructive
- Keywords
- Hypoglossal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Hypoglossal Nerve Stimulation | Experimental | Device: Implantable Hypoglossal Nerve Stimulation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older, regardless of sex.
- Moderate-to-severe obstructive sleep apnea confirmed by polysomnography, with an apnea-hypopnea index of 15 to 100 events per hour.
- Prior failure of, intolerance to, or unwillingness to continue positive airway pressure therapy.
- Body mass index ≤40 kg/m².
- Able to communicate with the investigator, understand the study requirements, and provide written informed consent.
Key exclusion criteria (10 listed)
- Central and mixed apnea and hypopnea events account for more than 25% of the total apnea-hypopnea index.
- 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.
- Abnormal hypoglossal nerve function; neurological or neuromuscular disease that may affect upper airway neuromuscular control or tongue movement; or clinically significant dysphagia.
- Severe cardiopulmonary disease, including but not limited to chronic obstructive pulmonary disease, severe asthma, chronic respiratory failure, myocardial infarction, or severe arrhythmia.
- Any disease or condition that precludes general anesthesia or may interfere with implantation of the hypoglossal nerve stimulation system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Hypoglossal Nerve Stimulation SystemThe investigational device is an implantable hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd. | Device | Implantable Hypoglossal Nerve Stimulation |
Primary outcome
Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3)
Time frame: 3 months after therapy activation
7 secondary outcomes
Response Based on the Oxygen Desaturation Index With a ≥3% Oxygen Desaturation Criterion (ODI3)
Time frame: 3 months after therapy activation
Change in Percentage of Total Sleep Time With Oxygen Saturation Below 90%
Time frame: 3 months after therapy activation
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: 3 months after therapy activation
Change in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) Total Score
Time frame: 3 months after therapy activation
Participant Investigator Equipment Satisfaction Evaluation
Time frame: 3 months after therapy activation
Investigator Equipment Satisfaction Evaluation
Time frame: 3 months after therapy activation
Malfunction Rates of External Devices and Accessories
Time frame: 3 months after therapy activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Hypoglossal Nerve Stimulation System in people with Obstructive Sleep Apnea (OSA) and Syndrome, Obstructive Sleep Apnea, run by Beijing Pins Medical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianguang Sun (010-60736388, sunjianguang@pinsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3) (time frame: 3 months after therapy activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.