Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Antwerp
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
Treatment groups
225 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov