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DISE-HNS Effect Study

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Trial details

Who runs it
University Hospital, Antwerp
Trial code
NCT06372847
Record updated
3 December 2025
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: 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).

ClinicalTrials.gov NCT06372847