Daytime versus overnight titration for hypoglossal nerve stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.