Daytime versus overnight titration for hypoglossal nerve stimulation
Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
We will test whether a daytime sleep test works as well as an overnight sleep test to fine-tune hypoglossal nerve stimulation for people with moderate to severe obstructive sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06559956 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective and retrospective non-inferiority study compares daytime polysomnography (PSG) to the conventional overnight PSG for titration of hypoglossal nerve stimulation (Inspire system). Two cohorts include patients who previously had an overnight titration as part of routine care and patients who recently had or will undergo a daytime titration at Antwerp University Hospital. The study collects PSG and home sleep test data, device usage and settings, and patient-reported outcomes (Epworth Sleepiness Scale, FOSQ-30, and a visual analogue snoring scale) across visits from pre-implant through 6- and 12-month follow-up. The primary goal is to determine whether daytime titration is non-inferior to overnight titration for optimizing stimulation settings.
Who should consider this trial
Good fit: Ideal candidates are adults with obstructive sleep apnea who have an implanted Inspire hypoglossal nerve stimulator and can give informed consent, and who either underwent an overnight titration at Antwerp University Hospital or are undergoing a daytime titration there.
Not a fit: Patients who cannot complete study questionnaires in the required language or who do not have an Inspire implant are not eligible and are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If daytime titration proves non-inferior, it could simplify follow-up care by offering shorter, daytime appointments that reduce burden on patients and sleep lab resources.
How similar studies have performed: Earlier feasibility work has suggested daytime PSG can be used for HNS titration, but robust head-to-head non-inferiority evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Olivier Vanderveken, MD, PhD — University Hospital, Antwerp
- Study coordinator: Dorine Van Loo, MSc
- Email: dorine.vanloo@uza.be
- Phone: +3238215780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.