Evaluating Safety and Effectiveness of Hypoglossal Nerve Stimulation in Young Children with Down Syndrome

Sleep apnea, characterized by nighttime breathing difficulties, significantly impacts children with Down syndrome, affecting up to 80% of this population compared to just 5% in the general pediatric community. This condition can hinder daily functioning and learning, and its effects may be even more profound in children with neurocognitive differences associated with Down syndrome. Traditional treatments such as tonsil or adenoid removal often prove less effective due to anatomical factors like enlarged tongues that can obstruct airways during sleep.

Recent research conducted by experts including Christopher Hartnick, MD, and Brian Skotko, MD, has explored the use of a hypoglossal nerve stimulator—a device that acts as a tongue pacemaker by moving the tongue forward to keep the airway open during sleep—in children with Down syndrome aged 13 to 21. Their earlier study demonstrated the safety and efficacy of this approach in adolescents, leading to FDA approval for this age group.

Building on this success, the current study aimed to assess whether this treatment could be safely and effectively used in younger children, specifically those between 4 and 13 years old. Since early childhood is critical for neurodevelopment, establishing safe intervention options could offer neurocognitive benefits alongside sleep improvements.

This retrospective review involved 29 children who underwent hypoglossal nerve stimulator surgery at Mass Eye and Ear and Phoenix Children's Hospital. These children had sleep studies conducted before surgery and at multiple intervals afterward, spanning up to three years. The multidisciplinary care teams involved emphasized the complexity of caring for children with Down syndrome, ensuring comprehensive management.

Results indicated that the procedure was safe, with no serious adverse events reported. Minor issues such as wound healing were resolved, and no complications related to the device were observed. Additionally, the children experienced notable improvements in sleep apnea severity: over 95% showed more than a 50% reduction in apnea episodes six months post-surgery. Their median apnea-hypopnea index decreased significantly from over 18 to nearly 4 events per hour.

These findings suggest that hypoglossal nerve stimulation is a promising treatment option for young children with Down syndrome, addressing concerns about safety as the device remains stable during growth. The results also provide valuable data for potential FDA approval for this age group. Importantly, the research offers hope to parents and caregivers by presenting an effective intervention to improve sleep and potentially neurocognitive development. Future plans include conducting trials to determine whether earlier intervention yields greater cognitive benefits, extending research into children aged 4 to 10.

This research underscores the importance of a specialized, multidisciplinary approach in managing sleep apnea in children with Down syndrome and highlights the potential for new therapies to improve quality of life and developmental outcomes.

Source: https://medicalxpress.com/news/2025-08-safety-efficacy-hypoglossal-nerve-young.html