Status:
RECRUITING
Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Obstructive Sleep Apnea
Sleep Apnea
Eligibility:
All Genders
18-99 years
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 ...
Detailed Description
This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnig...
Eligibility Criteria
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
Key Trial Info
Start Date :
August 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06559956
Start Date
August 27 2024
End Date
July 1 2028
Last Update
September 10 2025
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650