RECRUITINGINTERVENTIONAL

DISE-HNS Effect Study

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DEVICE

Hypoglossal nerve stimulation implant

The hypoglossal nerve stimulation (HNS) implantation and therapy will be performed according to the standard clinical practice without additional procedures. Information about the surgical procedure will be collected. HNS implant information and settings will be collected throughout the study until the last study measurement (one year follow-up PSG and DISE) for that patient. No additional measures or interventions as part of the research project will be performed during implantation or treatment with HNS.

DIAGNOSTIC_TEST

Polysomnography

A PSG at one-year follow-up is part of the standard follow-up pathway in patients receiving HNS therapy. In this study, PSG data will be collected from both baseline and one-year follow-up PSGs to assess treatment effect. Additionally, PSG data will be used for non-invasive prediction of the site and pattern of collapse using a novel, validated tool developed at our research group.

PROCEDURE

Drug-induced sleep endoscopy (DISE)

Drug-induced sleep endoscopy (DISE) is the clinical standard diagnostic test to assess site, pattern and degree of upper-airway collapse in OSA. Baseline DISE is part of the standard clinical pathway for HNS eligibility. In this study, DISE data will be collected from routine baseline DISE without any additional procedures for the patient. They will undergo an additional DISE at one-year follow-up to assess the effect of HNS-therapy on site, pattern and degree of collapse. Both DISEs will be performed according to routine clinical practice in the operating theatre. Sleep will be induced using 1.5 mg bolus injection midazolam and target-controlled propofol infusion (2.0 - 3.0 μg). A flexible fiberoptic nasopharyngoscope will be transnasally inserted. Site, pattern and degree of collapse will be assessed using a standardized scoring system. Other maneuvers, including chin-lift, the use of a simulation bite or lateral position of the head will be performed according to clinical practice.

Locations (1)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, Belgium