DISE and hypoglossal nerve stimulation effects on upper airway collapse
Official title: Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
Run by University Hospital, Antwerp · NCT06372847 · Data updated 2026-11-12
We will test whether a new non‑invasive method using raw sleep study (PSG) data can predict where the upper airway collapses before and during hypoglossal nerve stimulation in adults with obstructive sleep apnea.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerpen) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT06372847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older who are eligible for HNS (AHI 15–65/h, BMI <32 kg/m2, no complete concentric palatal collapse on DISE, prior CPAP or MAD intolerance/failure, central/mixed apneas <25%, and scheduled for HNS implantation at Antwerp University Hospital with a baseline PSG within two years) are ideal candidates.
✕Probably not a fit
Patients likely to gain little benefit include those with complete concentric collapse of the palate, BMI ≥32, predominantly central apnea, or those not receiving HNS at the Antwerp center.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for hypoglossal nerve stimulation (HNS) at Antwerp University Hospital will have baseline polysomnography (PSG) and drug‑induced sleep endoscopy (DISE) data reviewed, receive HNS implantation as standard care, and undergo repeat PSG and DISE about one year after therapy. The project compares the clinical DISE observations of site, pattern, and degree of collapse with predictions generated from raw PSG using a novel non‑invasive algorithm. Outcomes will be compared between patients who respond to HNS and those who do not to identify predictive features. All procedures follow routine clinical care with the additional analytical comparison of PSG‑based predictions against DISE findings.
Why it matters
Potential benefit: If successful, the method could improve selection of HNS candidates and personalize therapy by predicting where stimulation will reduce airway collapse, potentially improving outcomes and avoiding ineffective implants.
How similar studies have gone: Clinical use of DISE to guide HNS candidacy has supportive data, while PSG‑based prediction of collapse sites is a newer, less validated approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, Belgium Recruiting
Study contacts
- Principal investigator: Olivier M Vanderveken, MD, PhD — Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital
- Study coordinator: Eldar Tukanov, MD
- Email: eldar.tukanov@uza.be
- Phone: +32 3 821 82 47
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.