NCT06332404 Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
| NCT ID | NCT06332404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2024-04-18 |
| Primary Completion | 2034-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2024-04-18 with a primary completion date of 2034-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.
Eligibility Criteria
Inclusion Criteria: Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria: * At least 18 years old at the time of implantation * The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h) * The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy * Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE) Exclusion Criteria: * Body mass index (BMI) \>32 kg/m². * Combined mixed and central AHI is more than 25% of the total AHI * Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS * Patients with severely impaired neurological control over the upper airway * Pregnancy * Surgery performed on the soft palate in the past three months before implantation.
Contact & Investigator
Olivier Vanderveken, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT06332404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06332404 currently recruiting?
Yes, NCT06332404 is actively recruiting participants. Contact the research team at dorine.vanloo@uza.be for enrollment information.
Where is the NCT06332404 trial being conducted?
This trial is being conducted at Edegem, Belgium, Bruges, Belgium.
Who is sponsoring the NCT06332404 clinical trial?
NCT06332404 is sponsored by University Hospital, Antwerp. The principal investigator is Olivier Vanderveken, MD, PhD at University Hospital, Antwerp. The trial plans to enroll 225 participants.