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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
RECRUITING
Edegem
Contact Information
Primary
Eldar Tukanov, MD
eldar.tukanov@uza.be
+32 3 821 82 47
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 58
Treatments
Other: Receiving hypoglossal nerve stimulation (HNS)
All included patients will be part of this arm. Patients who are eligible for HNS-therapy for obstructive sleep apnea (OSA) will be invited to participate in the study. Data from the baseline PSG and baseline DISE as part of the standard pathway for HNS-eligibility will be accessed and collected. All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway. After one year of treatment, information from the one-year follow-up PSG as part of the standard pathway will be collected. Furthermore, patients will undergo an additional one-year follow-up DISE.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov