DISE and hypoglossal nerve stimulation effects on upper airway collapse

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Antwerp (Academic / other)
• Locations: 1 site (Edegem, Antwerpen)
• Trial ID: NCT06372847 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Clinical use of DISE to guide HNS candidacy has supportive data, while PSG‑based prediction of collapse sites is a newer, less validated approach.

Eligibility 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 this trial is running

Edegem, Antwerpen

• 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

Conditions Obstructive Sleep Apnea; Hypoglossal nerve stimulation; Drug-induced sleep endoscopy