Transitioning from wellness to medical claims requires rigorous randomized controlled trials (RCTs) with active sham controls. This paper breaks down the trial design that secured FDA De Novo clearance for a digital therapeutic for insomnia.
Developing an engaging digital control that provides general health education without active therapeutic components was critical to isolating the psychological mechanism of action.
The study demonstrated statistically significant improvements in sleep onset latency sustained at 6-month and 12-month follow-up visits, outperforming standard pharmaceutical regimens.