Follow-up on the Genio™ System for treating sleep apnea
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.
NA · Nyxoah S.A. · NCT04031040
This study is testing how well the Genio™ system works and how safe it is for adults with moderate to severe sleep apnea over five years after their surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nyxoah S.A. (industry) |
| Locations | 23 sites (Antwerp and 22 other locations) |
| Trial ID | NCT04031040 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of the Genio™ system in adults with moderate to severe obstructive sleep apnea (OSA) over a 5-year period following surgery. It is a multicenter, prospective, single-arm post-market clinical follow-up, where patients will be monitored at various intervals after the activation of the device. The study includes regular follow-ups through phone calls and in-person visits to assess the long-term outcomes of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a BMI less than 35 kg/m2 and an apnea-hypopnea index (AHI) between 15 to 65 events/hour who have not tolerated or have failed other treatments.
Not a fit: Patients with significant comorbidities that contraindicate surgery or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from obstructive sleep apnea who have not benefited from traditional therapies.
How similar studies have performed: Other studies on similar devices have shown promise, but this specific follow-up on the Genio™ system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body Mass Index (BMI) \< 35 kg/m2 * AHI between 15 to 65 events/hour documented by a PSG during the screening phase. * Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments. Exclusion Criteria: * Night shift worker * Significant comorbidities that contraindicates surgery * Life expectancy \< 12 months * Participation in another clinical study (excluding registries) during the study period (3 years).
Where this trial is running
Antwerp and 22 other locations
- Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn — Antwerp, Belgium (RECRUITING)
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (RECRUITING)
- CHU - Angers — Angers, France (SUSPENDED)
- Centre Hospitalier Intercommunal de Créteil — Créteil, France (SUSPENDED)
- Hôpital Henri-Mondor AP-HP — Créteil, France (SUSPENDED)
- Hôpital Privé La Louvière — Lille, France (SUSPENDED)
- Clinique Beau-Soleil — Montpellier, France (SUSPENDED)
- Hôpital Bichat, Assistance Publique - Hôpitaux de Paris — Paris, France (SUSPENDED)
- CEREVES Paris Jean Jaurès - Centre du sommeil — Paris, France (SUSPENDED)
- Hôpital Tenon AP-HP — Paris, France (SUSPENDED)
- CHU - Poitiers — Poitiers, France (SUSPENDED)
- Clinique Mutualiste de la Sagesse — Rennes, France (SUSPENDED)
- Polyclinique Saint Laurent — Rennes, France (SUSPENDED)
- CHU Toulouse — Toulouse, France (SUSPENDED)
- Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin — Berlin, Germany (NOT_YET_RECRUITING)
- Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie — Hamburg, Germany (RECRUITING)
- HNO-Klinik des Universitätsklinikums Jena — Jena, Germany (RECRUITING)
- Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum — Mannheim, Germany (RECRUITING)
- Klinikum rechts der Isar der TU München — München, Germany (RECRUITING)
- Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg — Regensburg, Germany (NOT_YET_RECRUITING)
- Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie — Wuppertal, Germany (ACTIVE_NOT_RECRUITING)
- Onze Lieve Vrouwe Gasthuis — Amsterdam, Netherlands (RECRUITING)
- Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie — Liestal, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Joachim T. Maurer, MD — Klinik für HNO-Heilkunde, Mannheim
- Study coordinator: Jey Subbaroyan, PhD
- Email: Jey.Subbaroyan@Nyxoah.com
- Phone: +1 (734) 277-3273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea