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EnrollingPhase 4 · Sleep Medicine · Device study

Obstructive Sleep Apnea — Genio® Implant

Real-world study testing the safety and effectiveness of the Genio® System 2.1, a bilateral hypoglossal nerve stimulation implant, in adults with moderate-to-severe obstructive sleep apnea.

What taking part involves

Duration
~5 years
Visits
9 visits (~2 per year)

A screening visit at our Miami office confirms whether a study is a fit. It is provided at no cost and you are under no obligation to continue.

Who may be able to take part

  • Adults 22–75
  • Moderate-to-severe OSA (AHI 15–65)
  • BMI ≤ 32 kg/m²
  • Failed, cannot tolerate, or not eligible for PAP/CPAP
  • Eligible for the Genio® implant (including DISE evaluation)

Final eligibility is determined at your free screening visit.

About this condition

Obstructive Sleep Apnea

In obstructive sleep apnea the muscles around the upper airway relax during sleep until the airway narrows or closes, interrupting breathing. Each pause ends in a brief awakening that restores breathing but fragments sleep, and the cycle can repeat dozens of times an hour without the sleeper being aware of it.

Common signs are loud snoring, breathing pauses noticed by a bed partner, waking unrefreshed, morning headache and daytime sleepiness. Severity is measured during a sleep study by the apnea-hypopnea index, the average number of breathing events per hour. Untreated, it is associated with high blood pressure, heart disease, stroke and type 2 diabetes. Positive airway pressure therapy is the standard treatment, though not everyone can tolerate it.

Read more about this condition

Other studies for this condition

If this one is not a fit, another may be. Our coordinators check you against every open protocol, not just the one you applied for.

See all studies for this condition

Registry record

This study is listed in the public registry of clinical studies. The record below is maintained by the study sponsor.

What happens after you apply

  1. 1
    Apply Online

    Fill out the short form below — it takes about two minutes and is completely confidential.

  2. 2
    Pre-Screening Call

    A bilingual research coordinator calls you within 24 hours to ask brief eligibility questions.

  3. 3
    Free Screening Visit

    Visit our Miami office for a no-cost medical evaluation: history, physical exam, and any required tests.

  4. 4
    Enroll & Begin

    If eligible, you are officially enrolled and begin the study under direct physician supervision.

Get Started

Apply for this study

Complete the form and a research coordinator will contact you within 24 hours. Se habla español.

Applying for: Obstructive Sleep Apnea — Genio® Implant (Phase 4)

1
Your Info
2
Study Interest

Prefer to talk? Call (305) 420-5636 — Se habla español.

See all open studies