Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not able to understand the language of the questionnaires
Trial population
Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Daytime titration polysomnography
Other interventionA 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Overnight titration polysomnography cohort0 interventions
Group B: Daytime titration polysomnography cohort1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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-up2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov