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Clinical Trials in Belgium / NCT06559956
Recruiting Observational

Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

NCT06559956 · tracked via the Priya Life Science Belgium tracker
Sponsor
University Hospital, Antwerp
Phase
Observational
Started
2024-08-27
Last updated
2025-09-10

Condition(s) studied

Obstructive Sleep ApneaSleep ApneaApnea

Investigational drug(s) / intervention(s)

Daytime titration polysomnography

Daytime titration polysomnography: A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.

Study summary

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options.

Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.

The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Patients diagnosed with OSA and implanted with HNS therapy (Inspire system) * Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital * Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital * Able to give informed consent Exclusion Criteria: * Not able to understand the language of the questionnaires

Primary outcome measure(s)

  • Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography — From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
    The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerp Recruiting

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3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry Recruiting
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults Active, not recruiting
Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea and Chronic Pain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06559956 on ClinicalTrials.gov ↗ ← All trials in Belgium