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DISE-HNS Effect Study — DISE-HNS  

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06372847
Study type Interventional
Source University Hospital, Antwerp
Contact Eldar Tukanov, MD
Phone +32 3 821 82 47
Email eldar.tukanov@uza.be
Status Not yet recruiting
Phase N/A
Start date April 23, 2024
Completion date March 31, 2028
View Details
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