Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04801771 | Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea | PHASE3 | ACTIVE NOT_RECRUITING | 57 | — | — | Jun 24, 2021 | Sep 30, 2027 | Sep 18, 2025 | 8 | United States |
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
| 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. |
| 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. |
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...