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Neurostimulation Device

Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (OSPREY Trial)

N/A
Recruiting
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

OSPREY Trial 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.Check my eligibility
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.See study design
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.

OSPREY Trial 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.

OSPREY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Change in CGI-S/CGI-I (Efficacy)
Change in EQ-5D (Efficacy)
Change in Epworth Sleepiness Scale (Efficacy)
+5 more

OSPREY 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the capacity of this experiment being tested?

"Affirmative. On clinicaltrials.gov, it can be confirmed that this medical research is actively recruiting volunteers; the trial was initially launched on July 27th 2021 and last changed on November 14th 2022. 150 participants need to join from 20 distinct sites of care."

Answered by AI

Is this research endeavor accepting new participants at the present time?

"This research is actively enrolling patients, as indicated by the most recent information posted on clinicaltrials.gov. This trial was first posted to this website on July 27th 2021 and has since seen amendments up until November 14th 2022."

Answered by AI

How many sites have been selected to conduct this clinical experiment?

"There are 20 clinical trial sites currently participating in this research endeavour, located in Louisville, Lincoln and Roseville as well as 17 other places. To minimize travel stressors for participants, selecting the closest location is recommended if you choose to join."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Maryland
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Paul Schalch Lepe, Md/Silenso Clinic
Advanced Ent Associates
Epic Medical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0

What questions have other patients asked about this trial?

How long is this study? How long will these tests take? How often do I have to come to Louisville?
PatientReceived no prior treatments
How long is the trial? Will it address a specific treatment plan? What is involved in the screening and do all procedures need to be conducting at the same location?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Treatment, feel better, sleep better. I have sleep apnea and on a cpap looking for alternative.
PatientReceived no prior treatments
I cannot tolerate a mask on my face and my nose clogs up when lying down. I'm looking for an alternative option to treat my obstructive Sleep Apnea.
PatientReceived 2+ prior treatments
I need help with sleep apnea cause Im over weight and have problem breathing.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Epic Medical Research: < 24 hours
  2. Medical University of South Carolina: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
2021. "Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04950894.
All > Apnea > Sleep Apnea
~41 spots leftby Apr 2025
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