Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Respiration Disorders; Obstructive Sleep Apnea (OSA); Sleep Apnea Syndrome, Obstructive; Syndrome, Obstructive Sleep Apnea
• Intervention / Treatment: Device: Implantable Hypoglossal Nerve Stimulation System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianguang Sun; Phone Number: 010-60736388; Email: sunjianguang@pinsmedical.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital
      • Contact: Jingying Ye; Phone Number: +86-13701396970; Email: yejingying@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantable Hypoglossal Nerve Stimulation	Device: Implantable Hypoglossal Nerve Stimulation System; The investigational device is an implantable hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3)	3 months after therapy activation

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Investigator Equipment Satisfaction Evaluation	3 months after therapy activation
Malfunction Rates of External Devices and Accessories	3 months after therapy activation

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hypoglossal nerve stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders
• Other Study ID Numbers: PNS6101&PINS-C2-01-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No