NCT06559956 Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
| NCT ID | NCT06559956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-08-27 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-08-27 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Olivier Vanderveken, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT06559956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06559956 currently recruiting?
Yes, NCT06559956 is actively recruiting participants. Contact the research team at dorine.vanloo@uza.be for enrollment information.
Where is the NCT06559956 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06559956 clinical trial?
NCT06559956 is sponsored by University Hospital, Antwerp. The principal investigator is Olivier Vanderveken, MD, PhD at University Hospital, Antwerp. The trial plans to enroll 110 participants.