Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy (DOT-PSG)

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Apnea; Sleep Apnea; Obstructive Sleep Apnea

Treatments: Other: Daytime titration polysomnography

Study type: Observational

Funder types: Other

Identifiers

NCT06559956

B3002024000122

Details and patient eligibility

About

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.

Full 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 overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.

Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring. Data will be collected from different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Overnight titration polysomnography cohort

Description:

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

Description:

OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG.

Treatment:

Other: Daytime titration polysomnography