Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
NCT Number: NCT06559956
Acronym: DOT-PSG
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea|Sleep Apnea|Apnea
Interventions: OTHER: Daytime titration polysomnography
Sponsor: University Hospital, Antwerp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2028-07
Locations: Antwerp University Hospital, Edegem, Antwerp, 2650, Belgium

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.

Primary Outcome Measures: Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography, 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, From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
Secondary Outcome Measures: 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, AHI is determined during a polysomnography, 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, 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, At the postoperative titration follow-up (approximately 3 months after activation of the therapy)|Full-night AHI as measured during a titration polysomnography, Full-night AHI is the AHI determined from the complete titration polysomnography., 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, Sleep architecture is the structure of the sleeping pattern, including rapid-eye movement sleep (REM) and nonREM sleep, and is measured during a polysomnography, 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, The body position is recorded during a polysomnography, At the postoperative titration follow-up (approximately 3 months after activation of the therapy)|Delta oxygen desaturation index (ODI) as measured by a polysomnography, The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during a polysomnography, 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, 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., 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, 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, 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, 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, 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, Average hours of therapy use per night can be retrieved from data stored in the device, 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, SASHB is calculated as the oxygen desaturation "area under the curve" in association with individual apneas and hypopneas, From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)