Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332404
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-13
Brief Title:
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea Belgian Registry
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Hypoglossal Nerve Stimulation HNS Therapy in Patients With Obstructive Sleep Apnea OSA Belgian Registry
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-HNS
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 registry of OSA patients that are treated with HNS Inspire system within routine clinical care at the Antwerp University Hospital
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None