Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
- Conditions
- Obstructive Sleep ApneaSleep ApneaApnea
- Interventions
- Other: Daytime titration polysomnography
- Registration Number
- NCT06559956
- Lead Sponsor
- University Hospital, Antwerp
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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
- Not able to understand the language of the questionnaires
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Daytime titration polysomnography cohort Daytime titration polysomnography OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG.
- Primary Outcome Measures
Name Time Method Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep
- Secondary Outcome Measures
Name Time Method Full-night AHI as measured during a titration polysomnography At the postoperative titration follow-up (approximately 3 months after activation of the therapy) Full-night AHI is the AHI determined from the complete titration polysomnography.
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 At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up AHI is determined during a polysomnography
Percent of time spent in each sleep stage as measured during a titration polysomnography At the postoperative titration follow-up (approximately 3 months after activation of the therapy) Sleep architecture is the structure of the sleeping pattern, including rapid-eye movement sleep (REM) and nonREM sleep, and is measured during a polysomnography
Percent of time spent in different body positions during a titration polysomnography At the postoperative titration follow-up (approximately 3 months after activation of the therapy) The body position is recorded during a polysomnography
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up The ESS questionnaire assesses the probability of falling asleep in various settings and situations in daily life. This questionnaire consists of eight questions which can be scored on a four-point Likert-type scale. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. The summation of the eight items can range from 0 to 24.
Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up The FOSQ-30 is a disease-specific quality of life questionnaire that determines functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The total score equals the mean scores for each subscale (5 in total) multiplied by the number of subscales answered (total score range 5-20, with higher scores indicating better functional status
Treatment AHI as measured during a titration polysomnography At the postoperative titration follow-up (approximately 3 months after activation of the therapy) The treatment AHI, also called the titrated AHI, is the AHI measurement from the portion of sleep when therapy is under therapeutic setting found for home use
Therapy adherence defined by the amount of hours therapy usage per night At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up Average hours of therapy use per night can be retrieved from data stored in the device
Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) SASHB is calculated as the oxygen desaturation "area under the curve" in association with individual apneas and hypopneas
Delta oxygen desaturation index (ODI) as measured by a polysomnography From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during a polysomnography
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up Snoring intensity is evaluated using a 10 cm visual analogue scale (VAS) from 0 to 10: 0 represents no snoring, 1-3 represents minimally annoying, 4-6 represents moderately annoying, 7-9 represents annoying, and 10 represents extremely annoying
Trial Locations
- Locations (1)
Antwerp University Hospital
🇧🇪Edegem, Antwerp, Belgium