Actively Recruiting
Home Sleep Therapy System for Mild Cognitive Impairment
Led by Brain Electrophysiology Laboratory Company · Updated on 2025-02-17
60
Participants Needed
2
Research Sites
N/A
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
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 Alzheimer's 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 Alzheimer's-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.
CONDITIONS
Brief Title
Home Sleep Therapy for Older Adults With MCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For participants with amnestic mild cognitive impairment (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 or epilepsy
- History of moderate or severe brain injury or trauma, including neurosurgery
- Presence of significant neurological diseases such as Parkinson's disease
- History of Electroconvulsive Therapy (ECT)
- Severe insomnia
- Untreated sleep apnea
- Severe anxiety or depression
- Use of medications that may affect EEG results
- History of stroke
- Sensitivity or allergy to lidocaine or silver
- Active suicidal thoughts
- Presence of metal in the head, implants, or medication infusion devices
- Pregnancy
- Adverse reactions to transcranial magnetic stimulation (TMS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants use the Sleep WISP device at home for up to nine sleep sessions including baseline, active or sham transcranial electrical stimulation (TES) nights, and nights of passive EEG recording to evaluate short-term enhancement of slow-wave sleep (SWS).
3 sleep sessions over 10 days at home
Duration - 6 weeks
Participants wear the Sleep WISP device nightly for two weeks receiving either sham or active TES, followed by a 2-week washout without device use, then another two weeks receiving the opposite condition to assess cumulative effects on slow-wave sleep and memory.
Nightly device use for 4 weeks total with 2 weeks washout; blood or nasal swab samples collected 4 times
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
P
Phan Luu, PhD
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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