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Not yet recruiting NCT07711678

Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

No phase Interventional Obstructive Sleep Apnea (OSA) Syndrome, Obstructive Sleep Apnea Respiration Disorders Sleep Apnea Syndrome, Obstructive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantable Hypoglossal Nerve Stimulation System.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea, Respiration Disorders, Sleep Apnea Syndrome, Obstructive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study of Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Overview

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).

Interventions

  • Device Implantable Hypoglossal Nerve Stimulation System
    The investigational device is an implantable hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.

Primary outcome measures

  • Response Based on the Apnea-Hypopnea Index With a ≥3% Oxygen Desaturation Criterion (AHI3) [Time frame: 3 months after therapy activation]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tsinghua Changgung Hospital — Beijing

Identifiers

NCT: NCT07711678 · PNS6101&PINS-C2-01-53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗