DISE-HNS Effect Study

NANot yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 23, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Obstructive Sleep Apnea
Interventions
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."

All Listed Sponsors
lead

University Hospital, Antwerp

OTHER

NCT06372847 - DISE-HNS Effect Study | Biotech Hunter | Biotech Hunter