Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inspire Upper Airway Stimulation System · 2 trials · 2 indications
Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline
Change in Cancellation scaled score of at least 0.5 standard deviation from baseline
Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline
Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline
Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline
Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.
The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
| Arm | Type | Description |
|---|---|---|
| Subjects implanted with Inspire UAS System | EXPERIMENTAL | Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System. |
| Inspire Therapy | EXPERIMENTAL | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
| Name | Type | Description |
|---|---|---|
| Inspire Upper Airway Stimulation (UAS) System | DEVICE | The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. |
| Inspire Upper Airway Stimulation System | DEVICE | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
Inclusion Criteria: * Diagnosis of Down syndrome * Age 10-21 years * Prior adenotonsillectomy * Severe OSA (AHI \> 10, AHI \< 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment * Approval from at l...