Clinical trial NCT06559956: Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Official title: Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Apnea
Keywords: hypoglossal nerve stimulation
titration polysomnography
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)

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 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).

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

Primary outcomes:
measure: Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Secondary outcomes:
measure: 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
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Treatment AHI as measured during a titration polysomnography
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
measure: Full-night AHI as measured during a titration polysomnography
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
measure: Percent of time spent in each sleep stage as measured during a titration polysomnography
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
measure: Percent of time spent in different body positions during a titration polysomnography
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)
measure: Delta oxygen desaturation index (ODI) as measured by a polysomnography
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Therapy adherence defined by the amount of hours therapy usage per night
timeFrame: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up
measure: Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography
timeFrame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Olivier Vanderveken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: