NCT06372847

DISE-HNS Effect Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE. To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-21
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2024-04-18
• Last updated: 2025-12-03

Locations

1 site across 1 country: Belgium