Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Key facts
- Where
- Edegem, BelgiumSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06559956, who can take part
Where in Belgium
- Antwerp University HospitalEdegem, BelgiumContact: Dorine Van Loo, MscTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.