The MEMOWAVE project: A phase I/II clinical trial targeting treatment of mild cognitive impairment through sound stimulation during slow‐wave sleep
Résumé
Background: Mild Cognitive Impairment (MCI) is a highly prevalent syndrome espe-cially among the elderly, but its treatment remains challenging. The MEMOWAVE project is a phase I/II randomized, double blind and cross-over clinical trial. The first objective is to validate the safety and tolerance of a device consisting of a small micro-phone, also equipped with electroencephalographic electrodes, inserted in the exter-nal ear canals. The device produces pink noises during slow-wave sleep based on real-time EEG acquisition. The second objective is to investigate the effectiveness of this device in amplifying cerebral slow waves during sleep through sound emission. The third objective is to study the effect of this stimulation on memory consolidation, atten-tion, executive functions, insight, creativity and mood in patients with MCI. Indeed, there is converging evidence that deep slow-wave sleep plays a major role in these aspects. This process has already shown improvements in memory performance in healthy subjects and during normal aging.
Method: Twenty-four patients between 40 and 85 years of age will spend three nights in a Center for sleep disorders. Their cognitive functions, insight, creativity abilities and mood will be tested before and after a night of slow wave stimulation or placebo (device in place without stimulation), in a randomized and crossover fashion.
Result: We expect that this device will represent a simple therapeutic approach, eas-ily tolerable by the patient, and able, if successful, of being offered quickly to a larger population of patients with MCI.
Conclusion: We are proposing a new innovative methodology for the treatment of MCI which we are going to test for safety and efficacy.