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Starting soon Not applicable

Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on Upper Airway Collapsibility During Drug-induced Sleep Endoscopy

NCT07337239 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2026-01
Last updated
2026-01-13

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Additional measurements during clinical standard follow-up drug-induced sleep endoscopy (DISE)

Additional measurements during clinical standard follow-up drug-induced sleep endoscopy (DISE): During standard DISE, type I polysomnography (Alice LDx 6, Philips Respironics) expanded with measurements of Pcrit (Pcrit3000 device, Philips Respironics) and airflow (Pneumotachometer, Hans-Rudolph, USA) will be performed.

Study summary

This clinical trial will evaluate the effect of treatment with hypoglossal nerve stimulation on the underlying mechanisms of obstructive sleep apnea. Several disease mechanism parameters are known to be associated with obstructive sleep apnea. However, currently, only the location of upper airway collapse is routinely examined in clinical practice using sleep endoscopy. Among other parameters, airway collapsibility is a widely studied mechanism. This parameter indicates how easily a patient's upper airway tends to collapse and can be assessed with additional measurements during sleep endoscopy.

The aim of this trial is to investigate the effect of hypoglossal nerve stimulation on collapsibility during sleep endoscopy. This information will provide a better understanding of the physiological mechanisms of hypoglossal nerve stimulation. In the long term, the investigators hope this knowledge will allow for more personalized care by tailoring treatment to the specific needs of each patient.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years or older. * Treated with HNS-therapy for OSA (AHI ≥15/hour sleep) * Capable of giving informed consent * Baseline polysomnography performed at Antwerp University Hospital Exclusion Criteria: * Patients did not receive HNS-therapy at the Antwerp University Hospital * Central apneas accounting for ≥25% of total apneas during baseline polysomnography * Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the participant). * Simultaneous use of other treatment modalities to treat OSA (outside of HNS-therapy) * Esophageal ulceration, tumors, diverticulitis, bleeding varices, sinusitis, epistaxis, recent nasopharyngeal surgery * Pregnancy or willing to become pregnant * Excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)

Primary outcome measure(s)

  • ΔPcrit — One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)
    Change in pharyngeal critical closing pressure (ΔPcrit), between baseline Pcrit and Pcrit with HNS. Both Pcrit measurements will be performed on the same day, during the 1-year follow-up DISE.

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerpen
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07337239 on ClinicalTrials.gov ↗ ← All trials in Belgium