Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daytime titration polysomnography.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Sleep Apnea, Apnea. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
Overview
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.
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 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).
Interventions
- Other 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.
Primary outcome measures
- Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Secondary outcome measures (11)
- Percent of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Treatment AHI as measured during a titration polysomnography [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
- Full-night AHI as measured during a titration polysomnography [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
- Percent of time spent in each sleep stage as measured during a titration polysomnography [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
- Percent of time spent in different body positions during a titration polysomnography [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
- Delta oxygen desaturation index (ODI) as measured by a polysomnography [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Therapy adherence defined by the amount of hours therapy usage per night [Time frame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
- Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography [Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Antwerp University Hospital — Edegem
Identifiers
NCT: NCT06559956 · B3002024000122