Hypoglossal nerve stimulator for obstructive sleep apnea in children with down syndrome younger than 13

Objective

Obstructive Sleep Apnea (OSA) is prevalent among children with Down syndrome (DS). While adenotonsillectomy is the first-line treatment for these patients, many do not achieve resolution of OSA. The U.S. Food and Drug Administration has approved HGNS implantation for children with DS, ages 13 and above. However, there remains a need for HGNS implantation in children under 13 with severe OSA. The objective of this study was to determine the safety and efficacy of HGNS placement in children <13 years of age with DS and severe OSA.

Study design

Retrospective cohort study.

Setting

Two academic institutions.

Methods

This study included children <13 years of age with DS and severe OSA who had HGNS implantation. Patient characteristics, postoperative complications, and response to therapy were recorded.

Results

A total of 29 children were included. The median age of the patients was 10 years old (range 4–12 years), with 19 patients (65.5 %) male. All 29 children were safely implanted with no serious adverse events. There was one mild wound dehiscence (Adverse Event), which resolved with antibiotic ointment and pressure dressing, and no adverse device effects. The median pre-op OAHI was 18.4 (IQR 13.2–22.3), and the median post-op OAHI was 3.9 (IQR 2.3–5.5) (p < 0.001). At 6 months post-op, 20 patients (95.2 %) had OAHI reduction of 50 % or more.

Conclusion

HGNS implantation in children with DS and severe OSA can be safely performed in children ages 4–13, and initial efficacy studies demonstrate outcomes similar to children over 13.