ABSTRACTAttention Deficit Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders and is associated with significant impairments in cognitive functioning. Moreover, the disorder is associated with increased anxiety and poor quality sleep, behaviors which may exacerbate and/or mimic ADHD symptomatology. As the autonomic nervous system (ANS) plays a critical role in modulating physiological levels of arousal, therapeutic strategies which target autonomic balance, such as vibrational therapy, may offer substantial benefits for anxiety and sleep. The Apollo system, a wearable vibrational therapy device designed for use on the wrist or ankle, has been found to promote greater autonomic balance by enhancing parasympathetic tone. However, its effects on sleep quality and anxiety levels in children with ADHD remain unclear. Objective: Therefore, the current study employed a double-blind, randomized sham-controlled design to evaluate the impact of the Apollo system on anxiety levels and sleep quality in children and adolescents (aged 8 to 17 years) with ADHD. Method: Participants were randomly assigned to either the active Apollo device, which delivers vibration to promote autonomic balance, or a sham device over a period of 8 weeks. Anxiety and sleep were assessed prior to and following this intervention period, using the Pittsburgh Sleep Quality Index (PSQI) and the trait subset of the State-Trait Anxiety Inventory (STAI). Conclusion: The findings indicate that utilizing a wrist/ankle-based vibrational therapy device 4 days per week for 2 hours a day over an 8-week period may be insufficient to meaningfully improve sleep outcomes and anxiety in children and adolescents with ADHD.
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