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

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Apnea; Sleep Apnea; Obstructive Sleep Apnea

Treatments: Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)

Study type: Observational

Funder types: Other

Identifiers

NCT06332404

B3002024000047

Details and patient eligibility

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.

Full description

Patients that are implanted with the Inspire system in Belgium 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).

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

• 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
• Pregnancy
• Surgery performed on the soft palate in the past three months before implantation.

Trial design

225 participants in 1 patient group

Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy

Description:

OSA patients treated with HNS therapy will be asked to participate in the registry.

Treatment:

Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)