clinicaltrials.gov Identifier: NCT2344108.

Objectives/Hypothesis Hypoglossal nerve (HGN) stimulation is a novel therapy for obstructive sleep apnea (OSA) in adults. Its efficacy and safety in children with Down syndrome (DS) was previously reported in a preliminary case series of six adolescents. Study Design Case series. Methods Twenty nonobese children and adolescents (aged 10–21 years) with DS and severe OSA (apnea‐hypopnea index [AHI] >10 and <50 events/hr) despite prior adenotonsillectomy were enrolled. Participants had failed a trial of continuous positive airway pressure therapy and underwent sleep endoscopy confirming surgical candidacy. The primary outcome was to assess safety and monitor for adverse events. Secondary outcomes included efficacy in reducing AHI (% reduction in AHI), adherence to therapy, and change in a validated quality‐of‐life instrument, the OSA‐18 survey. Results All 20 children (median age = 16.0 years [interquartile range = 13–17 years], 13 male) were implanted with no long‐term complications. We report two interval adverse events, both of which were corrected with revision surgery. Twenty participants completed the 2‐month polysomnogram, with median percent reduction in titration AHI of 85% (interquartile range = 75%–92%). The median nightly usage for these children was 9.21 hours/night. There was a median change in the OSA‐18 score of 1.15, indicating a moderate, yet significant, clinical change. Conclusions HGN stimulation was safe and effective in the study population. Two minor surgical complications were corrected surgically. Overall, these data suggest that pediatric HGN stimulation appears to be a safe and effective therapy for children with DS and refractory severe OSA. Level of Evidence 4 Laryngoscope, 130:E263–E267, 2020

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clinicaltrials.gov Identifier: NCT01255735.

The DI appears to be a valid and reliable instrument to assess quality of life in exercise-induced pediatric PVFM. A DI change of 8 or higher seems significant. This instrument can serve as an objective tool to assess change in exercise-induced pediatric PVFM following speech therapy.