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

Sponsor
University Hospital, Antwerp
Study ID
NCT07337239
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Additional measurements during clinical standard follow-up drug-induced sleep endoscopy (DISE) — PROCEDURE
    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 Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: DISE extended with additional measurements
    Patients who undergo hypoglossal nerve stimulation therapy will be recruited at the one year follow-up appointment at the department of ENT. As part of the standard clinical pathway, these patients will have a PSG and DISE planned one year after HNS-therapy intiation. Participants of this study will be invited to to have their one year follow-up DISE extended with additional measurements to assess the effect of HNS therapy on upper airway collapsibility.

Primary Outcome Measure

ΔPcrit [ Time Frame: One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS) ]

Central Contacts

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