DISE-HNS Effect Study

Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE

The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.

Furthermore, outcomes will be compared between responders and non-responders.

Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE.

To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation.

All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.

One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.

Inclusion Criteria:

• 18 years or older.
• Eligible for HNS-therapy:
• AHI between 15 and 65 events/hour
• BMI under 32 kg/m2
• Absence of complete concentric collapse of palate (CCC) on DISE
• Intolerance or failure of continuous positive airway pressure (CPAP)-treatment
• Intolerance or failure of mandibular advancement device (MAD)-treatment
• Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years)
• Scheduled for HNS-implantation at the Antwerp University Hospital
• Capable of giving informed consent
• Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital

Exclusion Criteria:

• Patients will not receive HNS-therapy at the Antwerp University Hospital
• Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).