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Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry — B-HNS  

Obstructive Sleep Apnea Clinical Trial

Official title:
Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry

Clinical Trial 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 registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital.

Clinical Trial Description

Patients that are implanted with the Inspire system at the Antwerp University Hospital will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring. Data will be collected from routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06332404
Study type Observational [Patient Registry]
Source University Hospital, Antwerp
Contact Dorine Van Loo, MSc
Phone +3238215780
Email dorine.vanloo@uza.be
Status Not yet recruiting
Phase
Start date March 2024
Completion date April 2034
View Details
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