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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240024 / PAS001 |
| Date Original Protocol Accepted |
11/07/2025
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| Date Current Protocol Accepted |
11/07/2025
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| Study Name |
Ext FU of the premarket cohort (DREAM Study)
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| Device Name |
Genio® System 2.1
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Multicenter clinical study design, continued follow-up of premarket cohorts, Single arm trial.
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| Study Population |
Patients who had the Genio system for the treatment of Obstructive sleep apnea with patients as their own controls.
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| Sample Size |
115
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| Key Study Endpoints |
First co-primary endpoint: percentage of responders at 12 months based on AHI4, a responder being defined as a participant who satisfies the following criteria: at least a 50% reduction from the average AHI4 of screening and baseline to 12 months post-surgery and a remaining AHI4 less than 20 at the 12-month visit (aka “Sher Criteria”), as measured with fixed therapeutic settings on full-night PSG (all scored by an independent core laboratory)
Second co-primary endpoint: percentage of responders at 12 months based on ODI4, a responder being defined as a participant who satisfies the following criterion: at least a 25% reduction from the average ODI4 of screening and baseline to 12 months post-surgery, as measured with fixed therapeutic settings on full-night PSG (all scored by an independent core laboratory).
Secondary Effectiveness Endpoint
• Mean change in the sleep-specific function measured by the Functional Outcomes of Sleep Questionnaire (FOSQ-10) at the 12-month visit compared to screening.
• Mean change in the OSA-specific quality of life measured by the SNORE-25 instrument at the 12-month visit compared to screening.
• Mean change in the sleep propensity measured by the ESS at the 12-month visit compared to screening.
• Mean change in the intermittent hypoxia measured by the ODI4 at the 12-month PSG compared to the average of screening and baseline.
• Mean change in the hypoxemic burden measured by the percentage of sleep time with oxyhemoglobin saturation < 90% at the 12-month PSG compared to the average of screening and baseline.
Mean change in OSA severity measured by the AHI4 at the 12-month PSG compared to the average of screening and baseline.
Safety will be evaluated by the incidence of device related serious adverse events recorded during the study for a period of 12 months post-surgery and in the long-term follow-up phase to 60 months post-surgery.
Adverse events will be adjudicated by an Independent Clinical Events Committee (CEC). An independent Data & Safety Monitoring Board (DSMB) will be established to review accumulated safety data from the trial.
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| Follow-up Visits and Length of Follow-up |
Upon completion of 12 months post-surgery, participants will be followed up to 5 years post-surgery for safety and efficacy.
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