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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dorine.vanloo@uza.be
• Phone: +3238215780

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.