Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
(OSPREY Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen byAtul Malhotra, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: LivaNova

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with moderate to severe obstructive sleep apnea who either can't or won't use positive airway pressure (PAP) therapy. It's not suitable for individuals with a BMI over 35, or those with certain respiratory, heart, kidney diseases, or other serious health issues.

Inclusion Criteria

I have been diagnosed with moderate to severe sleep apnea.

I cannot or choose not to use PAP therapy.

Exclusion Criteria

Specific PSG criteria outlined in the protocol

You have a body mass index (BMI) higher than 35, which means being significantly overweight.

I have a heart, lung, kidney disease, or other serious health conditions.

Participant Groups

The study tests the aura6000(R) System which stimulates the hypoglossal nerve to reduce sleep apnea events. Participants are chosen at random and observed in multiple centers to see if their sleep apnea improves without using PAP treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: ControlExperimental Treatment1 Intervention

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

Group II: ActiveActive Control1 Intervention

HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13