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NCT06372847

DISE-HNS Effect Study

Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
University Hospital, Antwerp·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Obstructive Sleep Apnea
Drug/Device/Intervention
Hypoglossal nerve stimulation implant
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
University Hospital, Antwerp
Timeline & enrollment
Phase
N/A
Start date
Apr 23, 2024
End date
Mar 31, 2028
Enrollment
58 participants
Primary outcome

Δ%area-of-collapse at the level of the lateral walls

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.

ICD-10 classifications
Sleep apnoeaSleep disordersSleep disorder, unspecifiedPrimary sleep apnoea of newbornNonorganic sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06372847
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06372847 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Antwerp and is currently Not yet recruiting. The study focuses on Obstructive Sleep Apnea. Target enrollment is 58 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.