Summit, NJNCT07331285Now EnrollingIRB Ready

Obstructive Sleep Apnea Clinical Trial in Summit, NJ

Access cutting-edge obstructive sleep apnea treatment through this clinical trial at a research site in Summit. Study-provided care at no cost to qualified participants.

Sponsored by Nyxoah Inc.

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Expert Care in Summit

Access obstructive sleep apnea specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related obstructive sleep apnea treatment provided free

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Check if you qualify for this obstructive sleep apnea clinical trial in Summit, NJ

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Summit

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Summit site if eligible
  4. 4Begin participation

About This Obstructive Sleep Apnea Study in Summit

The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.

Sponsor: Nyxoah Inc.

Who Can Participate

Inclusion Criteria

Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).
Be adults 22 years of age and older.
Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.
Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.
Agree to participate in the study and voluntarily sign and date an informed consent form.
Be willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits, evaluation procedures and questionnaires for the whole duration of the trial.
Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.

Exclusion Criteria

Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.
Women who are pregnant, planning to become pregnant or breastfeeding.
Any condition or procedure that has compromised neurological control of the upper airway.
Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
Patients below 22 or above 75 years of age.
Patients with a Body Mass Index (BMI) above 32 kg/m2.
Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr.
Patients with Complete Concentric Collapse (CCC) at the soft palate level.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Summit?

Yes, this clinical trial (NCT07331285) has an active research site in Summit, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obstructive Sleep Apnea Treatment Options in Summit, NJ

If you're searching for obstructive sleep apnea treatment options in Summit, NJ, this clinical trial (NCT07331285) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Summit research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obstructive sleep apnea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obstructive sleep apnea clinical trials near you to find additional studies recruiting in your area.

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