An interventional study of Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea, OSA and Apnea, sponsored by LivaNova. Completed at 19 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by LivaNova · Not applicable, Interventional, and Treatment
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.
The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 107 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →LivaNova is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Abbreviated: Additional criteria may apply:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Device: Hypoglossal Nerve Stimulation
HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13
Device: Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Rate of response to therapy when compared to no therapy for 6 months
The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.
Time frame: Month 1 through Month 7
Rate of all serious adverse device/procedure related events from time of implant through month 7
The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).
Time frame: Month 1 through Month 7
Decrease in Oxygen Desaturation Index (Efficacy)
Time frame: Baseline through Month 7
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Time frame: Baseline through Month 7
Change in Epworth Sleepiness Scale (Efficacy)
Time frame: Baseline through Month 7
Change in EQ-5D (Efficacy)
Time frame: Baseline through Month 7
Change in PROMIS SDI/SRI (Efficacy)
Time frame: Baseline through Month 7
Change in SF-36 (Efficacy)
Time frame: Baseline through Month 7
Change in CGI-S/CGI-I (Efficacy)
Time frame: Baseline through Month 7
Descriptive analysis of all reported Adverse Events (Safety)
Time frame: Consent through Month 7
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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