Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

(OSPREY Trial)

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

150 Participants Needed

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.

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 data supports the effectiveness of the treatment aura6000(R) System for obstructive sleep apnea?

Research shows that hypoglossal nerve stimulation, a treatment similar to the aura6000(R) System, has been effective in reducing the severity of obstructive sleep apnea in patients, with both short-term and long-term benefits. ^{1 2 3 4 5}

Is hypoglossal nerve stimulation safe for humans?

Hypoglossal nerve stimulation for obstructive sleep apnea has been studied and found to be generally safe, with no patients requiring surgical revision of the implanted system in a study involving 60 patients. However, there was a report of a serious complication (iatrogenic pneumothorax, which is a collapsed lung caused by medical treatment) during the implantation process. ^{6 7 8 9 10}

How is hypoglossal nerve stimulation treatment different from other treatments for obstructive sleep apnea?

Hypoglossal nerve stimulation is unique because it involves a surgical implant that stimulates the nerve controlling tongue muscles to keep the airway open during sleep, unlike other treatments like CPAP (continuous positive airway pressure) which use external devices to maintain airflow. ^{2 6 11 12 13}

Research Team

Atul Malhotra, MD

Principal Investigator

UCSD Pulmonary and Critical Care Medicine

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.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation for obstructive sleep apnea: A review of the literature. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Upper Airway Stimulation for OSA: Early Adherence and Outcome Results of One Center. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Iatrogenic pneumothorax during hypoglossal nerve stimulator implantation. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Implanted upper airway stimulation device for obstructive sleep apnea. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulation and Heart Rate Variability: Analysis of STAR Trial Responders. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Impulse Configuration in Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: The Effect of Modifying Pulse Width and Frequency. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. [2022]