Actively Recruiting
Home Sleep Therapy for Older Adults With MCI
Led by Brain Electrophysiology Laboratory Company · Updated on 2025-02-17
60
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
Sponsors
B
Brain Electrophysiology Laboratory Company
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Sleep Therapy for Older Adults With MCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For participants with Amnestic MCI, age must be between 55 and 85 years old
- For healthy volunteers without MCI, age must be between 40 and 80 years old
You will not qualify if you...
- History of seizures
- History of epilepsy
- History of moderate or severe brain injury or trauma, including neurosurgery
- History or presence of significant neurological diseases such as Parkinson's
- History of Electroconvulsive Therapy (ECT)
- Presence of severe insomnia
- Presence of untreated sleep apnea
- Presence of severe anxiety or depression
- Use of medications that may affect EEG
- History of stroke
- Sensitivity or allergy to lidocaine or silver
- Presence of active suicidal ideation
- Presence of metal in the head, implants, or medication infusion devices
- Pregnancy
- Adverse reaction to Transcranial Magnetic Stimulation (TMS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Not Yet Recruiting
2
Brain Electrophysiology Laboratory Company
Eugene, Oregon, United States, 97405
Actively Recruiting
Research Team
D
Don M Tucker, PhD
CONTACT
P
Phan Luu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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