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

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Trial details

Who runs it
University Hospital, Antwerp
Trial code
NCT06559956
Record updated
10 September 2025
Original description
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.Read full original descriptionShow less

Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea

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.

Inclusion: 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: Not able to understand the language of the questionnaires.

ClinicalTrials.gov NCT06559956