Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
ConditionObstructive Sleep Apnea (OSA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorXII Medical
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Pregnancy or breast-feeding.
Significant upper airway anatomic abnormalities
Hypoglossal nerve weakness
Central sleep apnoea condition
Trial design
Design model
Single group
Treatments tested in this trial
XII Medical HGNS System
DeviceXII Medical HGNS System
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: XII Medical HGNS SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the XII Medical HGNS System
Assessment of serious adverse device events
Time frame
Six months post-implantationSecondary outcomes
1
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Apnea Hypopnea Index
Time frame
Six months post-implantation2
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Oxygen Desaturation Index
Time frame
Six months post-implantationSponsors and contacts
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Source ClinicalTrials.gov