Actively Recruiting
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Led by University Hospital, Antwerp · Updated on 2025-09-10
110
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with obstructive sleep apnea and implanted with hypoglossal nerve stimulation therapy (Inspire system)
- Cohort 1: Patients who previously had an overnight titration polysomnography as part of routine care at Antwerp University Hospital
- Cohort 2: Patients who recently had or will undergo a daytime titration polysomnography at Antwerp University Hospital
- Able to provide informed consent
You will not qualify if you...
- Unable to understand the language of the questionnaires
AI-Screening
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Trial Site Locations
Total: 1 location
1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
D
Dorine Van Loo, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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