Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-27

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Obstructive Sleep Apnea Sleep Apnea Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

Daytime titration polysomnography

Intervention Type OTHER

A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.

Interventions

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Daytime titration polysomnography

A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.

Intervention Type OTHER

Eligibility Criteria

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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