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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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 multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge
RECRUITING
Bruges
Antwerp University Hospital
RECRUITING
Edegem
Contact Information
Primary
Dorine Van Loo, MSc
dorine.vanloo@uza.be
+3238215780
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2034-04
Participants
Target number of participants: 225
Treatments
Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy
OSA patients treated with HNS therapy will be asked to participate in the registry.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov