Non-invasive Sleep Enhancement Using Phase-Locked Auditory Stimulation to Improve Memory and Slow Cognitive Decline in Older Adults with Mild Cognitive Impairment

What this Trial Is About

Researchers are investigating a non-invasive method to improve memory and slow cognitive decline in older adults by enhancing the quality of deep, slow-wave sleep SWS. Dementia, a leading cause of death worldwide, is linked to disturbed sleep, especially the loss of SWS, which plays a key role in memory and clearing waste from the brain. Poor SWS may worsen memory loss and increase dementia risk. This study focuses on people with mild cognitive impairment and aims to test if phase-locked auditory stimulation PLAS can improve SWS and related brain functions. The study involves 60 older adults using a home-use SleepLoop device that delivers either real or sham soundless PLAS during sleep. Participants undergo two 4-week intervention periods separated by a 2-week washout phase. One group receives real PLAS first followed by sham stimulation, and the other group receives sham first then real PLAS. The device detects slow oscillations in sleep and delivers short sound stimuli during deep sleep to strengthen slow-wave brain activity. The stimulation is applied on weeknights, Monday to Friday, and is individually calibrated for each participant. Participants will play memory-testing serious games on weekdays during an adaptation week and throughout both intervention periods. Blood samples will be collected at baseline and after 4, 6, and 10 weeks to measure dementia-related markers. Sleep electrophysiology and cognitive tests will be performed regularly to assess changes. Researchers will monitor memory performance, brain activity during sleep, and blood biomarkers to evaluate the effects of PLAS. The total study duration includes adaptation, intervention, washout, and follow-up periods, extending up to 10 weeks for each participant.

Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment