Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Antwerp University Hospital
RECRUITING
Edegem
Contact Information
Primary
Dorine Van Loo, MSc
dorine.vanloo@uza.be
+3238215780
Time Frame
Start Date: 2024-08-27
Estimated Completion Date: 2028-07
Participants
Target number of participants: 110
Treatments
Overnight titration polysomnography cohort
A cohort of OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway
Daytime titration polysomnography cohort
OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov