Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Recruiting
N/A
Interventional Study
Obstructive Sleep Apnea (OSA)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 21 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 30 (estimated)
- Sponsor
- XII Medical · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 a…
Contacts