An observational study in Obstructive Sleep Apnea, Sleep Apnea and Apnea, sponsored by University Hospital, Antwerp. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by University Hospital, Antwerp · Observational
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.
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).
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 110 is close to the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
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Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A cohort of OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway
OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG.
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.
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
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
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
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
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
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
Full-night AHI is the AHI determined from the complete 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
Sleep architecture is the structure of the sleeping pattern, including rapid-eye movement sleep (REM) and nonREM sleep, and is measured during a 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
The body position is recorded during a 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
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep and will be determined during 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
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.
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
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
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
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
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
Average hours of therapy use per night can be retrieved from data stored in the device
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
SASHB is calculated as the oxygen desaturation "area under the curve" in association with individual apneas and hypopneas
Time frame: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
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