NCT05771844 · Brain Electrophysiology Laboratory Company
Home Sleep Therapy for Older Adults With MCI
What this study 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).
View original scientific description
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.
Interventions
DEVICE
Transcranial Electrical Stimulation
Oscillating electrical current
Primary outcome measures
Device Usability
Time frame: Collected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study.
Criteria for success: the prototype is safe for all participants, and it is usable at home by 80% of adults with MCI. Specific outcome ratings (5-point Lickert scale) will be obtained for (1) ability to clean the device, (2) ability to apply the device, (3) ability to turn on the tablet (launching the dedicated software); (4) ability to start treatment; (5) ability to complete treatment.
Duration of N3 Sleep
Time frame: Measured during the nights of sleep (typically 8 hours) across both phases of the study
Duration in minutes of N3 sleep
Percentage of N3 Sleep
Time frame: Measured during the nights of sleep (typically 8 hours) across both phases of the study
Percentage of the night's sleep spent in N3
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Adverse reaction to TMS
Where
- Winston-Salem, North Carolina
- Eugene, Oregon
Collaborators
National Institute on Aging (NIA), Wake Forest University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2025 · Source of record for eligibility and locations