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NCT04950894 · ClinicalTrials.gov registry record · NA

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

A NA study of Obstructive Sleep Apnea and OSA, sponsored by LivaNova.

Active
Registry status
NA
Development phase
150
Enrollment target
20
Study locations

NCT04950894 is a NA study of Obstructive Sleep Apnea and OSA that is active but no longer recruiting, run by LivaNova. The registered enrollment target is 150 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04950894, a NA study of Obstructive Sleep Apnea and OSA, is active but no longer recruiting, sponsored by LivaNova.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DEVICE Hypoglossal Nerve Stimulation

Study Locations (20)

Arizona

  • Banner Health - Phoenix
  • University of Arizona - Tucson

California

  • Sacramento Ent - Roseville
  • Paul Schalch Lepe, Md/Silenso Clinic - San Diego

Florida

  • Sleep Medicine Specialists of South Florida - Miami
  • Morton Plant Mease Health Care - Safety Harbor

Pennsylvania

  • Penn State Health - Hershey
  • Philadelphia Ear, Nose and Throat Associates - Philadelphia

South Carolina

  • Medical University of South Carolina - Charleston
  • Bogan Sleep Consultants, Llc - Columbia

Texas

  • Houston Methodist - Houston
  • Epic Medical Research - Red Oak

Alabama

  • University of Alabama At Birmingham - Birmingham

Georgia

  • Advanced Ent Associates - Atlanta

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-07-27
Est. Completion 2025-10-30
Phase NA

Sponsor

LivaNova

13 total trials

What the Registry Record Tells You About NCT04950894

The ClinicalTrials.gov registry entry for NCT04950894 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (32% lower). The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Hypoglossal Nerve Stimulation is the first listed.

NCT04950894 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04950894 about?

NCT04950894 is a clinical study titled "Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation". 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.

What is the current status of trial NCT04950894?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-07-27. Estimated completion is 2025-10-30.

What conditions does trial NCT04950894 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, OSA, Apnea, Obstructive Sleep, Apnea, Hypopnea, Sleep.

What interventions are being tested in trial NCT04950894?

The interventions under investigation include: Hypoglossal Nerve Stimulation (DEVICE).

Who is sponsoring clinical trial NCT04950894?

This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04950894 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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