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

January 6, 2026 updated by: University Hospital, Antwerp

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea (OSA) is one of the most prevalent respiratory disorders, characterized by recurrent pharyngeal collapses during sleep. This disturbance results in fragmented, nonrestorative sleep. Furthermore, intermittent hypoxemia can lead to both acute and chronic elevation of blood pressure and serves as a significant risk factor for all-cause mortality. OSA symptoms include snoring, unrefreshing sleep, fatigue, excessive sleepiness and nocturnal gasping or choking.

OSA is diagnosed using polysomnography (PSG), during which several parameters are measured throughout the night, including airflow, electroencephalography, electromyography, oxygen desaturation and heart rate. Using these measures, OSA severity is quantified by the apnea-hypopnea index (AHI), capturing the number of apneas and hypopneas per hour of sleep.

The standard treatment for OSA is continuous positive airway pressure (CPAP), which opens the upper airway by creating a pneumatic splint. Alternative treatments include mandibular advancement device (MAD) treatment, which (re)opens the upper airway by protruding the mandible, positional therapy to avoid supine position, drug treatments, hypoglossal nerve stimulation treatment and other surgical treatments. While CPAP is characterized by an overall greater efficacy, adherence might be limited. Non-CPAP treatments are characterized by a higher adherence, yet their efficacy is patient dependent.

Respiration-synchronized hypoglossal nerve stimulation (HNS) is an innovative technique in which the hypoglossal nerve is stimulated to protrude the tongue during inspiration. While HNS has demonstrated clinical efficacy, its impact on the underlying pathophysiological mechanisms of OSA remains insufficiently understood. Five pathophysiological parameters are known to be associated with OSA treatment outcome: site of collapse, upper airway collapsibility, ventilatory control instability (loop gain), muscle responsiveness and arousal threshold. These key pathophysiological traits have also been shown to be associated with HNS treatment outcome.

Currently, only the site of collapse is routinely assessed in clinical practice using drug-induced sleep endoscopy (DISE). The remaining traits, particularly collapsibility, usually require complex overnight pressure-drop studies that are not feasible for routine clinical use. Collapsibility is commonly assessed in research using the critical closing pressure (Pcrit), where a higher Pcrit indicates a more collapsible airway.

A recent technique developed by our research group allows for the assessment of the critical closing pressure (Pcrit) during DISE using a modified nasal mask and CPAP device. While the clinical effectiveness of HNS is proven, its specific effect on upper airway collapsibility is unknown.

This study aims to quantify the effect of HNS on upper airway collapsibility by measuring Pcrit during DISE, both with and without active stimulation. This research is vital for understanding the mechanical effects of HNS therapy and may ultimately improve patient selection and the delivery of personalized medicine for OSA.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Antwerp University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔPcrit in responders and in non-responders
Time Frame: One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)
ΔPcrit in responders and in non-responders. Treatment responders are defined by the Sher15 criteria (AHI decrease of >50% and total AHI<15/h).
One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)
∆AHI from baseline to one-year follow-up
Time Frame: From baseline (PSG at baseline, before implantation of hypoglossal nerve stimulator) to one-year follow-up
∆AHI from baseline to one-year follow-up to measure treatment response
From baseline (PSG at baseline, before implantation of hypoglossal nerve stimulator) to one-year follow-up
Δ%area-of-collapse at the level of the palate, tongue base, lateral walls and epiglottis
Time Frame: One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)
Δ%area-of-collapse at the level of the palate, tongue base, lateral walls and epiglottis, between baseline DISE and DISE with HNS
One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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