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ACTIVE NOT RECRUITING NA

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

NCT03868618 · View on ClinicalTrials.gov ↗

Study Summary

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Conditions Studied

Interventions

  • DEVICE Genio™ system

Study Locations (20)

Florida

  • ENT and Allegy Associates South Florida — Boca Raton
  • University of South Florida-Tampa General Medical Center — Tampa

Ohio

  • The Ohio State University, Wexner Medical Center — Columbus
  • Ohio Sleep Medicine Institute — Dublin

Pennsylvania

  • Thomas Jefferson University Department of Otolaryngology — Philadelphia
  • University of Pennsylvania — Philadelphia

Tennessee

  • The University of Tennessee Health Science Center- Dept. of Otolaryngology — Memphis
  • Vanderbilt University Medical Center — Nashville

Alabama

  • University of Alabama at Birmingham — Birmingham

Georgia

  • Advanced Ear Nose & Throat Associates — Atlanta

Indiana

  • CENTA (Center for ENT & Allergy) — Carmel

Iowa

  • University of Iowa- Institute for Clinical & Translational Science — Iowa City

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2020-10-14
Est. Completion 2028-02
Phase NA

Sponsor

Nyxoah S.A.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03868618

The ClinicalTrials.gov registry entry for NCT03868618 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nyxoah S.A., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention — of which Genio™ system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03868618 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03868618 about?

NCT03868618 is a clinical study titled "Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)". A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

What is the current status of trial NCT03868618?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 115 participants. The study started on 2020-10-14. Estimated completion is 2028-02.

What conditions does trial NCT03868618 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03868618?

The interventions under investigation include: Genio™ system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03868618?

This trial is sponsored by Nyxoah S.A., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03868618 being conducted?

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

Related

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