Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

Launched by UNIVERSITY HOSPITAL, ANTWERP · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called hypoglossal nerve stimulation (HNS) to help patients with moderate to severe obstructive sleep apnea (OSA) who have not had success with other treatments, like CPAP machines or dental devices. The Inspire system is a device that stimulates the nerve controlling the tongue, helping to keep the airway open during sleep. The goal of this trial is to create a registry of patients treated with this system at the Antwerp University Hospital in Belgium, as the treatment has recently been approved for reimbursement in the country.

To participate in the trial, patients must be at least 18 years old, diagnosed with moderate to severe OSA, and have not had success with CPAP or dental devices. Participants will be those who can safely have the Inspire device implanted. It’s important to note that certain conditions, such as a high body mass index or specific airway issues, may exclude someone from joining. Those who qualify can expect regular follow-ups to monitor their health and how well the Inspire system is working for them.

Gender

ALL

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.