Home Sleep Therapy Using Non-Invasive Brain Stimulation to Improve Deep Sleep and Memory in Older Adults with Mild Cognitive Impairment

What this Trial Is About

This research aims to evaluate the use of non-invasive transcranial electrical stimulation TES during deep slow-wave sleep in older adults with mild cognitive impairment MCI. The study seeks to understand if TES delivered by a home-use sleep therapy device called SleepWISP can enhance deep sleep and improve memory performance. Additionally, the study will explore biomarkers related to Alzheimers disease, such as beta-amyloid levels, to better understand potential links between sleep enhancement and disease markers. Participants will use the SleepWISP device, which includes a 16-channel EEG headband and electrical stimulation capabilities. The device measures brain activity during sleep and delivers low-level electrical current during slow-wave sleep to potentially increase its duration. The study has two phases Phase I involves up to nine sleep sessions with baseline, TES, and sham conditions to test short-term effects, while Phase II is a six-week repeated-measures trial comparing TES and sham treatments in participants with and without MCI. Participants will also wear actigraphy watches to measure movement and sleep parameters. During the study, participants will complete memory tests before and after sleep sessions to assess memory retention. Blood samples or nasal swabs will be collected multiple times to measure Alzheimers-related biomarkers. The study will monitor device usability daily and measure the duration and percentage of deep sleep during nights of participation. Participants will be observed for up to six weeks, with various assessments including depression inventories and memory performance tests to evaluate cognitive changes and safety.

Home Sleep Therapy for Older Adults With MCI