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NCT04950894: OSPREY
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
NA trial testing Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea in 150 participants. Participants enrolled and being followed up; not accepting new ones.
30 October 2024
Quick facts
| Lead sponsor | LivaNova |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 27 July 2021 |
| Primary completion | 30 October 2024 |
| Estimated completion | 30 October 2025 |
| Sites | 20 locations across United States |
Drugs / interventions tested
- Hypoglossal Nerve Stimulation
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
- OSA — all drugs for OSA →
- Apnea — all drugs for Apnea →
- Apnea, Obstructive — all drugs for Apnea, Obstructive →
Sponsor
LivaNova — full company profile →
Who can join
22 and older, any sex, with Obstructive Sleep Apnea or OSA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Reimagining obstructive sleep apnoea: a new era for sleep medicine.
Kundel V, Cohen O, Shah N. · · 2023 · cited 5× · PMID 37914468 · DOI 10.1016/s2213-2600(23)00372-7 -
Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial.
Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, et al · · 2022 · cited 5× · PMID 35613672 · DOI 10.1016/j.cct.2022.106804 -
Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled Trial.
Malhotra A, Schwartz AR, Lovett E, Juran N, et al · · 2026 · PMID 42008810 · DOI 10.7326/annals-25-04414
Verify or expand the search:
- PubMed search for NCT04950894
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hypoglossal Nerve Stimulation
Trials testing the same drug.
- NCT04322097 — Mechanisms of Upper Airway Obstruction · NA · completed
Other recruiting trials for Obstructive Sleep Apnea
Currently open trials in the same condition.
- NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
- NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
- NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
- NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
- NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting
Other LivaNova trials
Trials by the same sponsor.
- NCT05975931 — IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes. · terminated
- NCT04779814 — Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in · terminated
- NCT04753385 — The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment mea · terminated
- NCT04282681 — XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU) · withdrawn
- NCT03887715 — A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Thera · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04950894 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LivaNova
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04950894.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing