Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

NCT07711678 | Not Yet Recruiting

• 1 other identifier: PNS6101&PINS-C2-01-53
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Hypoglossal nerve stimulation

Outcome Measures

Primary Outcomes (1)

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

  3 months after therapy activation

Secondary Outcomes (7)

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

  3 months after therapy activation

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

  3 months after therapy activation

• Change in Epworth Sleepiness Scale (ESS) Score

  3 months after therapy activation

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

  3 months after therapy activation

• Participant Investigator Equipment Satisfaction Evaluation

  3 months after therapy activation

Study Arms (1)

Implantable Hypoglossal Nerve Stimulation

EXPERIMENTAL

Device: Implantable Hypoglossal Nerve Stimulation System

Interventions

Implantable Hypoglossal Nerve Stimulation System DEVICE

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

Implantable Hypoglossal Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Respiration Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Jianguang Sun

CONTACT

010-60736388; sunjianguang@pinsmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)