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Hypoglossal nerve stimulator for obstructive sleep apnea in children with down syndrome younger than 13
Minjee Kim1, Lucy J Xu1, E'Ching Shih1
1Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.
Insights
Hypoglossal nerve stimulation (HGNS) implantation is safe and effective for treating severe obstructive sleep apnea (OSA) in children with Down syndrome (DS) under 13. This procedure shows promising outcomes comparable to older patients, offering a new treatment option.
Area of Science:
- Pediatric Otolaryngology
- Sleep Medicine
- Genetics
Background:
- Obstructive Sleep Apnea (OSA) is common in children with Down syndrome (DS).
- Adenotonsillectomy is the primary treatment, but often fails to resolve OSA in this population.
- Hypoglossal Nerve Stimulation (HGNS) is FDA-approved for DS patients aged 13+, but a need exists for younger children with severe OSA.
Purpose of the Study:
- To evaluate the safety and efficacy of HGNS implantation in children under 13 with Down syndrome and severe OSA.
- To assess postoperative complications and treatment response in this pediatric cohort.
Main Methods:
- Retrospective cohort study conducted at two academic institutions.
- Included 29 children under 13 with DS and severe OSA who underwent HGNS implantation.
- Recorded patient demographics, surgical complications, and polysomnographic data (pre- and post-operative Apnea-Hypopnea Index).
Main Results:
- All 29 children (ages 4-12) were safely implanted with no serious adverse events; one mild wound complication resolved.
- Median preoperative Apnea-Hypopnea Index (OAHI) was 18.4, significantly decreasing to 3.9 postoperatively (p < 0.001).
- At 6 months, 95.2% of patients achieved a ≥50% reduction in OAHI.
Conclusions:
- HGNS implantation is a safe procedure for children aged 4-13 with Down syndrome and severe OSA.
- Initial efficacy results indicate outcomes similar to those observed in patients over 13.
- This study supports HGNS as a viable treatment option for severe OSA in younger children with DS.
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.
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