Actively Recruiting
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
Led by University Hospital, Antwerp · Updated on 2025-09-15
225
Participants Needed
2
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient implanted with or receiving the Inspire HNS system and able to give informed consent
- At least 18 years old at the time of implantation
- Moderate to severe obstructive sleep apnea (AHI between 15 and 65 events per hour)
- Failed, not tolerated, or contraindicated for CPAP and/or mandibular advancement device therapy
- No complete concentric collapse of the soft palate during Drug-Induced Sleep Endoscopy (DISE)
You will not qualify if you...
- Body mass index (BMI) greater than 32 kg/m²
- Mixed and central apnea-hypopnea index more than 25% of total AHI
- Complete concentric collapse at the soft palate or anatomical issues impeding HNS function
- Severely impaired neurological control over the upper airway
- Pregnancy
- Surgery on the soft palate within 3 months before implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
2
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium, 8000
Actively Recruiting
Research Team
D
Dorine Van Loo, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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