Study Protocol for a Randomized Controlled Trial Assessing the Effectiveness of Personalized Computerized Cognitive Training for Individuals With Insomnia

Abstract

Insomnia is a frequent and heightened pathology in the general population of developed countries, and its condition generally leads to health discomfort and performance drop in daily and work-related tasks. As current pharmacological treatments for insomnia do not always seem sufficient to mitigate impairment, contemporary cognitive approaches might shed light on developing complementary therapies for this population. We propose a cognitive stimulation intervention program based on the importance of cognitive abilities as precipitating and maintenance variables of sleep disturbances. A full phase I-II-III clinical trial is proposed in which the first two studies will serve to assess the safety of the intervention and to identify the maximum tolerated time of the computerized cognitive training (phase I) and the minimum effective number of training sessions (phase II) in the absence of adverse events or side effects. Next, a phase-III double-blind randomized controlled trial design will be set. Sixty individuals with insomnia aged 25 to 55 years will enroll in a home-based personalized computerized cognitive stimulation program for a total time of 8 weeks, training 5 days per week. Sixty insomnia patients matched in a variety of factors will constitute the active control group, where the orthogonal activities will not be cognitively demanding. Sleep, cognitive, emotional, and quality of life variables will be measured before and immediately after training. A linear mixed model and hierarchical regression analysis will be used to investigate intervention effects. The results derived from this study will be precious for future research and treatment in cognitive performance and clinical pathologies.Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT05050292].

Enhancing Executive Functions in Pediatric Epilepsy: Feasibility and Efficacy of a Computerized Cognitive Training Program

“…This method aims to recover, compensate, or enhance cognitive functions through training or the repetitive practice of specific strategies [18]. Its efficacy in enhancing cognitive mechanisms in individuals with epilepsy is particularly promising, considering the proven utility of cognitive stimulation programs in rehabilitating executive functions in disorders such as Attention Deficit Hyperactivity Disorder (ADHD) [19,20], Autism Spectrum Disorder (ASD) [21], insomnia [22], cancer-related cognitive impairment (CRCI) [23], post-acute sequelae of COVID-19 (PASC) [24], and schizophrenia [25], among others.…”

Digital Therapeutics for Insomnia: Assessing the Effectiveness of a Computerized Home-Based Cognitive Stimulation Program

“…Therefore, here we propose to evaluate the optimal training time and safety of a CTT for insomnia, to provide continuity to the implementation of the program over a longer period. In the current study, we present the results of Phase I/II of the clinical trial proposed by Tapia and colleagues [45]. After being enlisted by their physician, a trained clinician interviewed potential participants for suitability.…”

Digital therapeutics for insomnia: Assessing the effectiveness of a computerized home-based cognitive stimulation program

“…Therefore, here we propose to evaluate the optimal training time and safety of a CTT for insomnia, with the aim of providing continuity to the implementation of the program over a longer period. In the current study, we present the results of Phase I/ II of the clinical trial proposed by Tapia and colleagues [33].…”