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Neurostimulation Device

Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (OSPREY Trial)

N/A
Waitlist Available
Led By Atul Malhotra, MD
Research Sponsored by LivaNova
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of moderate to severe OSA
Declines to use or does not tolerate PAP therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 through month 7
Awards & highlights

Summary

This trial is testing a new system to help people with sleep apnea who can't or don't want to use positive airway pressure treatment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, changes in speech patterns during stimulation, tongue movement disturbances, and possible local tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with moderate to severe sleep apnea.
Select...
I cannot or choose not to use PAP therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 through month 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 through month 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of all serious adverse device/procedure related events from time of implant through month 7
Rate of response to therapy when compared to no therapy for 6 months

Trial Design

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

Find a Location

Who is running the clinical trial?

LivaNovaLead Sponsor
64 Previous Clinical Trials
32,495 Total Patients Enrolled
Atul Malhotra, MDPrincipal InvestigatorUCSD Pulmonary and Critical Care Medicine
11 Previous Clinical Trials
755 Total Patients Enrolled

Media Library

aura6000(R) System (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04950894 — N/A
Obstructive Sleep Apnea Research Study Groups: Active, Control
Obstructive Sleep Apnea Clinical Trial 2023: aura6000(R) System Highlights & Side Effects. Trial Name: NCT04950894 — N/A
aura6000(R) System (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04950894 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT04950894 — N/A
~0 spots leftby Oct 2024
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