Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on Upper Airway Collapsibility During Drug-induced Sleep Endoscopy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Additional measurements during clinical standard follow-up drug-induced sleep endoscopy (DISE)

    Procedure/Surgery

    During 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

21 Participants
are divided into 1 treatment group
Group A: DISE extended with additional measurementsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)

Secondary outcomes

1

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).

Time frame
One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)
2

∆AHI from baseline to one-year follow-up

∆AHI from baseline to one-year follow-up to measure treatment response

Time frame
From baseline (PSG at baseline, before implantation of hypoglossal nerve stimulator) to one-year follow-up
3

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

Time frame
One year after HNS implantation, during the 1-year follow-up DISE (= DISE at baseline & DISE with HNS)

Other outcomes

Sponsors and contacts

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