Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

(OSPREY Trial)

Not currently recruiting at 19 trial locations

Overseen By EDWARD MEZERHANE, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LivaNova

Disqualifiers: Respiratory, cardiac, renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the aura6000(R) System, a device for hypoglossal nerve stimulation, can reduce breathing problems in individuals with moderate to severe obstructive sleep apnea. It targets those who cannot or prefer not to use machines like CPAP, which assist with breathing during sleep. Participants may join a group that begins treatment immediately or one that starts later. This trial suits adults diagnosed with sleep apnea who have difficulty using traditional sleep masks. As an unphased trial, it provides a unique opportunity to explore new treatment options for sleep apnea.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the aura6000(R) System is safe for treating obstructive sleep apnea?

Research has shown that the aura6000 System for treating obstructive sleep apnea is generally safe. Studies have found it to be well-tolerated, with safety confirmed in several long-term studies. In one study, 65% of patients responded positively over 12 months, indicating that many benefit from the treatment without major problems. The aura6000 System uses hypoglossal nerve stimulation, which several studies have reported as safe and effective, with high patient satisfaction and adherence. Although similar devices have reported side effects, the overall evidence supports the safety of the aura6000 System for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obstructive sleep apnea, such as CPAP machines and oral appliances, the aura6000(R) System uses hypoglossal nerve stimulation to keep the airway open during sleep. This unique approach targets the muscles controlling the tongue, preventing airway collapse without the need for a mask or mouthpiece. Researchers are excited about this treatment because it offers a potentially more comfortable and less intrusive solution for patients, with the possibility of improving adherence and effectiveness compared to traditional therapies.

What evidence suggests that the aura6000(R) System is effective for obstructive sleep apnea?

Research shows that the aura6000 System, which stimulates a nerve in the tongue, effectively treats obstructive sleep apnea. In a previous study, 65% of patients experienced significant improvement, with at least a 50% reduction in breathing interruptions during sleep. This trial will compare two groups: one group will have the aura6000 System activated at Month 1, while the control group will have it activated at Month 7. This nerve stimulation can also enhance sleep quality and patient satisfaction. Other studies have found that this treatment significantly reduces the number of breathing interruptions, making it a promising option for people with moderate to severe obstructive sleep apnea. Overall, evidence suggests that the aura6000 System could be a safe and effective treatment for those who do not respond well to other methods. ^{1 2 4 5 6}

Who Is on the Research Team?

Atul Malhotra, MD

Principal Investigator

UCSD Pulmonary and Critical Care Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

All qualifying subjects will be implanted with the aura6000(R) System

1 day

Randomization

Subjects are randomized 2:1 in favor of Stimulation therapy (Active Group) following implant and prior to the Month 1 visit

1 day

Treatment

Active group starts Stimulation therapy at Month 1; Control group continues current treatment until Month 7, then starts Stimulation therapy

12 months

Follow-up

Safety and efficacy are evaluated at Month 7 and Month 13

6 months

What Are the Treatments Tested in This Trial?

Interventions

• aura6000(R) System

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 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: Active Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

LivaNova

Lead Sponsor

Trials

66

Recruited

31,100+

Vladimir A. Makatsaria

LivaNova

Chief Executive Officer since 2024

Bachelor of Arts in Physiology, Master of Healthcare Administration, and Master of Business Administration from the University of Minnesota

Dr. Deanna Wilke

LivaNova

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

Hypoglossal nerve stimulation is a promising treatment for obstructive sleep apnea, with a very low overall rate of serious adverse events (<2%) reported in initial trials, indicating its safety.

Despite the low complication rate, there is a risk of iatrogenic pneumothorax during the procedure, highlighting the need for surgeons to be aware of this potential issue and prepared to manage it effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic pneumothorax during hypoglossal nerve stimulator implantation. Arteaga, AA., Pitts, KD., Lewis, AF.[2019]

The Genio™ system for bilateral hypoglossal nerve stimulation (HNS) significantly reduced the severity of obstructive sleep apnea (OSA) after 6 months, with the apnoea-hypopnoea index (AHI) decreasing from 23.7 to 12.9 events per hour (p<0.001).

Participants also reported improvements in daytime sleepiness and sleep-related quality of life, with no serious device-related adverse events occurring during the study, indicating a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eastwood, PR., Barnes, M., MacKay, SG., et al.[2021]

The Upper Airway Stimulation (UAS) system is shown to be a safe and effective treatment for moderate to severe obstructive sleep apnea (OSA) in patients who are unable or unwilling to use CPAP, with significant improvements in apnea hypopnea index (AHI) and sleep quality measures after 6 months.

Successful therapy response was associated with specific baseline characteristics, including a body mass index (BMI) of 32 or less and an AHI of 50 or less, indicating that patient selection can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted upper airway stimulation device for obstructive sleep apnea. Van de Heyning, PH., Badr, MS., Baskin, JZ., et al.[2022]

In a study involving 60 patients with obstructive sleep apnea, selective upper airway stimulation significantly reduced the apnea-hypopnea index from an average of 28.6 events per hour to 8.3 events per hour after 6 months, indicating strong efficacy in improving sleep quality.

All patients reported improvements in sleep and daytime symptoms, and there were no surgical revisions required for the implanted system, highlighting the safety of this new surgical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. Heiser, C., Maurer, JT., Hofauer, B., et al.[2022]

Hypoglossal nerve stimulation (HNS) therapy is FDA-approved for treating moderate-to-severe obstructive sleep apnea (OSA) in patients who cannot tolerate CPAP, with specific criteria including a body mass index <32 and an apnea-hypopnea index <50.

The STAR trial demonstrated that HNS therapy can provide significant therapeutic benefits for certain OSA patients, although the results may not apply to all individuals with OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation for obstructive sleep apnea: A review of the literature. Wray, CM., Thaler, ER.[2022]

Ultrasonographic assessment of hyoid bone excursion (HBE) during hypoglossal nerve stimulation (HGNS) programming can effectively optimize therapy for obstructive sleep apnea, as it correlates with treatment outcomes.

In a study of 17 subjects, those who responded to HGNS (showing a significant reduction in apnea hypopnea index) had greater HBE, indicating that monitoring tongue movement can help predict and enhance the efficacy of HGNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. Korotun, M., Quintero, L., Shikowitz, M., et al.[2022]

Hypoglossal nerve stimulation (HNS) has shown promising results in treating moderate-to-severe obstructive sleep apnea (OSA), with follow-up studies indicating similar or improved apnea-hypopnea index (AHI) outcomes since the Inspire device's FDA approval in 2014.

The use of drug-induced sedation endoscopy (DISE) has emerged as a valuable tool for assessing patient eligibility for HNS, highlighting the importance of a coordinated approach between medical and surgical management for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. Strohl, MM., Yamauchi, M., Peng, Z., et al.[2022]

In a study of 76 patients with obstructive sleep apnea, hypoglossal nerve stimulation significantly improved sleep metrics, reducing the median apnea-hypopnea index from 30.0 to 18.6 events per hour and the Epworth Sleepiness Scale from 13.5 to 7.6 after 12 months.

Modifying stimulation parameters from 90 μsec at 33 Hz to 120 μsec at 40 Hz reduced the voltage needed for effective tongue protrusion, indicating a potential for optimizing treatment while maintaining efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impulse Configuration in Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: The Effect of Modifying Pulse Width and Frequency. Steffen, A., Jeschke, S., Soose, RJ., et al.[2022]

In a study of 31 subjects with moderate to severe obstructive sleep apnea, hypoglossal nerve stimulation significantly reduced the severity of the condition, as shown by a decrease in the apnea-hypopnea index from 45.4 to 25.3 events per hour after 12 months.

The treatment was used regularly, averaging 5.4 hours per night, and led to improved sleep quality, with no significant adverse events occurring after the first 6 months, indicating both safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. Kezirian, EJ., Goding, GS., Malhotra, A., et al.[2022]

Citations

1. investor.livanova.com investor.livanova.com/news-releases/news-release-details/livanova-announces-12-month-data-osprey-clinical-study-moderate

LivaNova Announces 12-month Data from OSPREY Clinical ... Top-line results at 12 months of treatment show meaningful improvement over time: Overall responder rate of 65%

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02263859

Targeted Hypoglossal Neurostimulation Study #3 (THN3) The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8738404/

Hypoglossal nerve stimulation for obstructive sleep apnea In therapy responders, HNS with respiratory sensing can normalize sleep-related quality of life with very good patient satisfaction [27, 28].

4. pharmexec.com pharmexec.com/view/livanova-aura6000-system-high-response-rate-moderate-severe-obstructive-sleep-apnea

LivaNova's aura6000 System Demonstrates High ... The aura6000 system showed a 65% responder rate at 12 months in patients with obstructive sleep apnea, defined as achieving at least a 50% reduction in apnea- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124003019

Hypoglossal nerve stimulation for obstructive sleep apnea ... Results show that HGNS is an effective and safe treatment option. The Inspire device significantly improved, reducing the apnea-hypopnea index (AHI) by −20.14 ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19115890&pc=MNQ

MAUDE Adverse Event Report: LIVANOVA USA, INC ... This is to report and gcp non-compliance of a medical device trial for livanova vns therapy device aura5000.