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NCT04950894: OSPREY

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Active, enrolled NA Last updated 1 May 2025
What this trial tests

NA trial testing Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea in 150 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
27 July 2021
Primary endpoint
30 October 2024
30 October 2025

Quick facts

Lead sponsorLivaNova
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment150
Start date27 July 2021
Primary completion30 October 2024
Estimated completion30 October 2025
Sites20 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of Hypoglossal Nerve Stimulation

Trials testing the same drug.

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

Other LivaNova trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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