About this trial
This clinical trial will evaluate the effect of treatment with hypoglossal nerve stimulation on the underlying mechanisms of obstructive sleep apnea. Several disease mechanism parameters are known to be associated with obstructive sleep apnea. However, currently, only the location of upper airway collapse is routinely examined in clinical practice using sleep endoscopy. Among other parameters, airway collapsibility is a widely studied mechanism. This parameter indicates how easily a patient's upper airway tends to collapse and can be assessed with additional measurements during sleep endoscopy.
The aim of this trial is to investigate the effect of hypoglossal nerve stimulation on collapsibility during sleep endoscopy. This information will provide a better understanding of the physiological mechanisms of hypoglossal nerve stimulation. In the long term, the investigators hope this knowledge will allow for more personalized care by tailoring treatment to the specific needs of each patient.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Treated with HNS-therapy for OSA (AHI ≥15/hour sleep)
Capable of giving informed consent
Baseline polysomnography performed at Antwerp University Hospital
Disqualifiers
Patients did not receive HNS-therapy at the Antwerp University Hospital
Central apneas accounting for ≥25% of total apneas during baseline polysomnography
Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the participant).
Simultaneous use of other treatment modalities to treat OSA (outside of HNS-therapy)
Trial design
Single group
Treatments tested in this trial
Additional measurements during clinical standard follow-up drug-induced sleep endoscopy (DISE)
Procedure/SurgeryDuring standard DISE, type I polysomnography (Alice LDx 6, Philips Respironics) expanded with measurements of Pcrit (Pcrit3000 device, Philips Respironics) and airflow (Pneumotachometer, Hans-Rudolph, USA) will be performed.
Treatment groups
Trial outcomes
Primary outcomes
ΔPcrit
Change in pharyngeal critical closing pressure (ΔPcrit), between baseline Pcrit and Pcrit with HNS. Both Pcrit measurements will be performed on the same day, during the 1-year follow-up DISE.
Secondary outcomes
ΔPcrit in responders and in non-responders
ΔPcrit in responders and in non-responders. Treatment responders are defined by the Sher15 criteria (AHI decrease of \>50% and total AHI\<15/h).
∆AHI from baseline to one-year follow-up
∆AHI from baseline to one-year follow-up to measure treatment response
Δ%area-of-collapse at the level of the palate, tongue base, lateral walls and epiglottis
Δ%area-of-collapse at the level of the palate, tongue base, lateral walls and epiglottis, between baseline DISE and DISE with HNS
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: