Obstructive Sleep ApneaOSPREYNCT04950894
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
A study testing Hypoglossal Nerve Stimulation in people with Obstructive Sleep Apnea and OSA, run by LivaNova at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, OSA, Apnea
- What is being tested?
- Hypoglossal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 19 sitesUnited States
- Study dates
- 24 Feb 2022to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe OSA
- Declines to use or does not tolerate PAP therapy
Who cannot join
- Respiratory, cardiac, renal disease or other co-morbid conditions
- BMI > 35 kg/m2
- Specific PSG criteria outlined in the protocol
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Advanced Ent Associates
Atlanta, Georgia, 30342
University of Alabama At Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
Bogan Sleep Consultants, Llc
Columbia, South Carolina, 29201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Health
Hershey, Pennsylvania, 17033
Houston Methodist
Houston, Texas, 77030
Alivation Research Llc
Lincoln, Nebraska, 68526
Norton Healthcare
Louisville, Kentucky, 40218
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126
Weill Cornell Medical College
New York, New York, 10024
Lankenau Hospital
Philadelphia, Pennsylvania, 19107
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, 27607
Epic Medical Research
Red Oak, Texas, 75154
Sacramento Ent
Roseville, California, 95661
Morton Plant Mease Health Care
Safety Harbor, Florida, 34695
University of Utah
Salt Lake City, Utah, 84108
Paul Schalch Lepe, Md/Silenso Clinic
San Diego, California, 92130
University of Arizona
Tucson, Arizona, 85724
About this study
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.
Read the detailed description
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.
The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
- Conditions
- Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea
- Being tested
- Hypoglossal Nerve Stimulation
- Keywords
- OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal Nerve StimulationDevice
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 Receives: Device: Hypoglossal Nerve Stimulation |
| Control | Other | 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 Receives: Device: Hypoglossal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Month 1 through Month 7
Secondary outcomes (8)
Decrease in Oxygen Desaturation Index (Efficacy)
Measured: Baseline through Month 7
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Measured: Baseline through Month 7
Change in Epworth Sleepiness Scale (Efficacy)
Measured: Baseline through Month 7
Change in EQ-5D (Efficacy)
Measured: Baseline through Month 7
Change in PROMIS SDI/SRI (Efficacy)
Measured: Baseline through Month 7
Change in SF-36 (Efficacy)
Measured: Baseline through Month 7
Change in CGI-S/CGI-I (Efficacy)
Measured: Baseline through Month 7
Descriptive analysis of all reported Adverse Events (Safety)
Measured: Consent through Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start24 Feb 2022
- Primary completion17 Oct 2024
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13. Additionally, the long-term phase allows for continued collection of data for safety, efficacy, and quality of life for up to four years from the time the subject completes the final M13 visit.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul Malhotra, MD, Principal investigator, UCSD Pulmonary and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950894
- Sponsor's protocol ID
- LNS005
- Acronym
- OSPREY
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Malhotra A, Schwartz AR, Lovett E, Juran N, Nguyen SA, Barrera JE, Bogan RK, Mickelson SA, Boghara H, Miller M, Jacobowitz O; OSPREY Investigators. Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled Trial. Ann Intern Med. 2026 Jun;179(6):812-822. doi: 10.7326/ANNALS-25-04414. Epub 2026 Apr 21.
PubMed 42008810Jacobowitz 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.
PubMed 35613672
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
- ClinicalTrials.gov ID
- NCT04950894
- Acronym / sponsor ID
- OSPREY / LNS005
- Conditions
- Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea
- Keywords
- OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.
The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13. Additionally, the long-term phase allows for continued collection of data for safety, efficacy, and quality of life for up to four years from the time the subject completes the final M13 visit.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Hypoglossal Nerve StimulationHGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 |
| Control | Other | Device: Hypoglossal Nerve StimulationHGN 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of moderate to severe OSA
- Declines to use or does not tolerate PAP therapy
Key exclusion criteria (3 listed)
- Respiratory, cardiac, renal disease or other co-morbid conditions
- BMI > 35 kg/m2
- Specific PSG criteria outlined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal Nerve StimulationHypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day) | Device | Active, Control |
Primary outcome
Rate of response to therapy when compared to no therapy for 6 months
Time frame: Month 1 through Month 7
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.
Rate of all serious adverse device/procedure related events from time of implant through month 7
Time frame: Month 1 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).
8 secondary outcomes
Decrease in Oxygen Desaturation Index (Efficacy)
Time frame: Baseline through Month 7
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Time frame: Baseline through Month 7
Change in Epworth Sleepiness Scale (Efficacy)
Time frame: Baseline through Month 7
Change in EQ-5D (Efficacy)
Time frame: Baseline through Month 7
Change in PROMIS SDI/SRI (Efficacy)
Time frame: Baseline through Month 7
Change in SF-36 (Efficacy)
Time frame: Baseline through Month 7
Change in CGI-S/CGI-I (Efficacy)
Time frame: Baseline through Month 7
Descriptive analysis of all reported Adverse Events (Safety)
Time frame: Consent through Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 42008810Malhotra A, Schwartz AR, Lovett E, Juran N, Nguyen SA, Barrera JE, Bogan RK, Mickelson SA, Boghara H, Miller M, Jacobowitz O; OSPREY Investigators. Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled Trial. Ann Intern Med. 2026 Jun;179(6):812-822. doi: 10.7326/ANNALS-25-04414. Epub 2026 Apr 21.
- Derived from this study: PubMed 35613672Jacobowitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Malhotra, MD principal investigator
UCSD Pulmonary and Critical Care Medicine
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal Nerve Stimulation in people with Obstructive Sleep Apnea and OSA, run by LivaNova at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of response to therapy when compared to no therapy for 6 months (time frame: Month 1 through Month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.