Ebb Insomnia Therapy is based on recent advances in understanding the neural systems that are important to the neurobiology of insomnia. By focusing on this, Ebb Insomnia Therapy can target its therapeutic impact and not interfere with other neural systems that might cause side effects.
Evidence suggests that sleep may serve a restorative function. Central to this is restoration, or reduction in metabolic activity in the frontal cortex during deeper stages of sleep where delta EEG spectral power (1-4Hz) is maximal.
Insomnia patients demonstrate high levels of frontal cortex metabolism during sleep that does not allow the normal restorative properties of sleep to occur. This is consistent with the hyper-arousal model of insomnia and is consistent with insomnia patients describing their minds as “racing.”
By using localized cooling to the forehead, Ebb Insomnia Therapy has been shown to reduce metabolic activity in the frontal cortex both before and during sleep. Reduction in brain metabolism by means of cooling is an established method in other medical disciplines where this technique is used for its neuroprotective effects, but the beneficial effects of regionally localized cooling have not previously been used in the management of insomnia until now.
We conducted three independent clinical studies on more than 230 patients over 3,800 research nights to demonstrate the safety and efficacy of Ebb Insomnia Therapy. The primary study was a prospective, randomized controlled trial involving two nights of therapy in 106 adults diagnosed with primary insomnia. Subjects were assessed by polysomnographic (PSG) recordings, and frequency and severity of adverse events. Ebb Insomnia Therapy produced improvements in insomniacs’ ability to fall asleep as shown by improvements in latencies to stage 1 and 2 sleep and demonstrated a benign safety profile.
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