Registry for patients with obstructive sleep apnea treated with hypoglossal nerve stimulation

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

This study is collecting information from patients with moderate to severe obstructive sleep apnea who are using a new device called Inspire to see how well it works and how it helps them over five years.

Quick facts

• Study type: Observational
• Enrollment: 225 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University Hospital, Antwerp (Academic / other)
• Locations: 2 sites (Edegem, Antwerp and 1 other locations)
• Trial ID: NCT06332404 on ClinicalTrials.gov

What this trial studies

This registry aims to collect data on patients with moderate to severe obstructive sleep apnea (OSA) who are treated with hypoglossal nerve stimulation (HNS) using the Inspire system in Belgium. Patients implanted with the Inspire device will be invited to participate, and data will be gathered during routine clinical visits over a five-year period. The collected data will include polysomnographic results, therapy usage, device performance, and patient-reported outcomes through various questionnaires. This observational approach allows for the assessment of the effectiveness and safety of HNS therapy in a real-world clinical setting.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older with moderate to severe obstructive sleep apnea who have not responded to or cannot tolerate traditional treatments like CPAP.

Not a fit: Patients with a body mass index over 32 kg/m² or those with specific anatomical issues that could hinder the effectiveness of the HNS therapy may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term effectiveness and safety of hypoglossal nerve stimulation therapy for patients with obstructive sleep apnea.

How similar studies have performed: While this registry approach is not novel, similar studies have shown success in evaluating the effectiveness of hypoglossal nerve stimulation in other populations.

Eligibility criteria

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.

Where this trial is running

Edegem, Antwerp and 1 other locations

• Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
• AZ Sint-Jan Brugge — Bruges, West-Vlaanderen, Belgium (Recruiting)

Study contacts

• Principal investigator: Olivier Vanderveken, MD, PhD — University Hospital, Antwerp
• Study coordinator: Dorine Van Loo, MSc

Conditions Obstructive Sleep Apnea; Sleep Apnea; Apnea; hypoglossal nerve stimulation; registry; routine clinical care