Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06372847

DISE-HNS Effect Study

Led by University Hospital, Antwerp · Updated on 2025-12-03

58

Participants Needed

1

Research Sites

127 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DISE-HNS Effect Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Apnea-hypopnea index (AHI) between 15 and 65 events/hour
  • Body mass index (BMI) under 32 kg/m2
  • No complete concentric collapse of the palate (CCC) on drug-induced sleep endoscopy (DISE)
  • Intolerance or failure of continuous positive airway pressure (CPAP) treatment
  • Intolerance or failure of mandibular advancement device (MAD) treatment
  • Combined central and mixed apneas less than 25% of total apneas on recent polysomnography (PSG) within two years
  • Scheduled for hypoglossal nerve stimulation (HNS) implantation at Antwerp University Hospital
  • Able to give informed consent
  • Baseline polysomnography planned or performed in the last 2 years at Antwerp University Hospital
Not Eligible

You will not qualify if you...

  • Not receiving hypoglossal nerve stimulation (HNS) therapy at Antwerp University Hospital
  • History of intellectual disability, memory disorders, or current psychiatric disorders including psychotic illness, major depression, or acute anxiety attacks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

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Research Team

E

Eldar Tukanov, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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