Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea (BEAT OSA)

XII Medical

Status

Enrolling

Conditions

Obstructive Sleep Apnea (OSA)

Treatments

Device: XII Medical HGNS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07049744

XII-002

Details and patient eligibility

About

The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have moderate to severe Obstructive Sleep Apnea (OSA).

Participation in this study involves being implanted with a Neurostimulator which provides electrical stimulation of the hypoglossal nerve (HGN). Participants will receive treatment at home during sleep, and participate in sleep studies to track and record the quality of the sleep. Participants will be monitored over the course of the study.

Enrollment

30 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) ≤ 32 kg/m2
AHI of 15-50 events/hour
Central + mixed apnea index ≤ 25%
Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)

Exclusion criteria

Pregnancy or breast-feeding.
Significant upper airway anatomic abnormalities
Hypoglossal nerve weakness
Central sleep apnoea condition
Significant positionally-dependent OSA.
Complete concentric patterns of soft palate collapse on DISE
Inadequately treated non-OSA sleep disorder(s).
Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia
Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture
Participants on a GLP-1