Home › Mild Cognitive Impairment › NCT05771844
Home Sleep Therapy for Older Adults With MCI
Home Sleep Therapy System for Mild Cognitive Impairment
Who can join
Ages 40 to 85 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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 during sleep along with an actigraphy watch that measures their movement throughout the day. In addition, blood samples or nasal swab assays will be collected from participants multiple times during the study.
What is being tested
- Transcranial Electrical Stimulation (device)
Sponsor: Brain Electrophysiology Laboratory Company · Participants: 60 · Started: Feb 8, 2023
Contact the study team
- Don M Tucker, PhD · Phone: 541-653-8266
- Phan Luu, PhD · Phone: 541-653-9797
Official record on ClinicalTrials.gov — NCT05771844
Locations in the U.S.
| North Carolina | Wake Forest University, Winston-Salem (Not yet recruiting) |
| Oregon | Brain Electrophysiology Laboratory Company, Eugene |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.