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Home Sleep Therapy for Older Adults With MCI

RecruitingNAAges 40 Years - 85 YearsAllBrain Electrophysiology Laboratory Company
NCT05771844 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in people with mild cognitive impairment via home use sleep therapy device (SleepWISP) as well as learn about biomarkers associated with Alzheimer disease (AD). The clinical trial aims to answer the following main questions: 1. Whether the non-invasive transcranial electrical stimulation (TES) delivered by SleepWISP could provide short-term enhancement of deep sleep in a single night in the target population. 2. Whether TES delivered by SleepWISP could enhance deep sleep over multiple nights in the target population. 3. Whether enhance on deep sleep could improve memory performance in the target population. Participants will be asked to wear non-invasive and painless devices that record their brain activity durin

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📋 Eligibility rules (as published)
Inclusion Criteria: * For participant with Amnestic MCI, the inclusion age range is 55-85 years old. * For healthy volunteers without MCI, the inclusion age range is 40-80 years old. Exclusion Criteria: * History of seizures * History of epilepsy * History of mod/severe brain injury or trauma (including neurosurgery) * History or presence of significant neurological disease such as Parkinson * History of Electroconvulsive Therapy (ECT) * Presence of severe insomnia * Presence of untreated sleep apnea * Presence of severe anxiety or depression * Medications that may affect the EEG * History of stroke * Sensitivity or allergy to lidocaine or silver * Presence of active suicidal ideation * Presence of metal in head or implants or medication infusion device * Pregnancy * Adverse reaction to TMS
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What it tests

  • Transcranial Electrical Stimulation
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Where

2 sites
Wake Forest University
Winston-Salem, United States
Brain Electrophysiology Laboratory Company
Eugene, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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