Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
OSPREY
1 other identifier
interventional
150
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMay 1, 2025
April 1, 2025
3.3 years
June 18, 2021
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of response to therapy when compared to no therapy for 6 months
The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.
Month 1 through Month 7
Rate of all serious adverse device/procedure related events from time of implant through month 7
The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).
Month 1 through Month 7
Secondary Outcomes (8)
Decrease in Oxygen Desaturation Index (Efficacy)
Baseline through Month 7
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Baseline through Month 7
Change in Epworth Sleepiness Scale (Efficacy)
Baseline through Month 7
Change in EQ-5D (Efficacy)
Baseline through Month 7
Change in PROMIS SDI/SRI (Efficacy)
Baseline through Month 7
- +3 more secondary outcomes
Study Arms (2)
Active
ACTIVE COMPARATORHGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Control
OTHERHGN 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
Interventions
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate to severe OSA
- Declines to use or does not tolerate PAP therapy
You may not qualify if:
- Respiratory, cardiac, renal disease or other co-morbid conditions
- BMI \> 35 kg/m2
- Specific PSG criteria outlined in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (20)
University of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Banner Health
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85724, United States
Sacramento Ent
Roseville, California, 95661, United States
Paul Schalch Lepe, Md/Silenso Clinic
San Diego, California, 92130, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126, United States
Morton Plant Mease Health Care
Safety Harbor, Florida, 34695, United States
Advanced Ent Associates
Atlanta, Georgia, 30342, United States
Norton Healthcare
Louisville, Kentucky, 40218, United States
Alivation Research Llc
Lincoln, Nebraska, 68526, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Weill Cornell Medical College
New York, New York, 10024, United States
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, 27607, United States
Penn State Health
Hershey, Pennsylvania, 17033, United States
Philadelphia Ear, Nose and Throat Associates
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Bogan Sleep Consultants, Llc
Columbia, South Carolina, 29201, United States
Houston Methodist
Houston, Texas, 77030, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (1)
Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016/j.cct.2022.106804. Epub 2022 May 22.
PMID: 35613672DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Atul Malhotra, MD
UCSD Pulmonary and Critical Care Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- PSG results are masked from the Investigator and Outcomes Assessor.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
July 6, 2021
Study Start
July 27, 2021
Primary Completion
October 30, 2024
Study Completion
October 30, 2025
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share