NCT07608614 · University of Washington
Sleep and Performance
(MTEC Phase 2)
What this study is about
This research is being done to apply new, contrast-free MRI (Magnetic Resonance Imaging) methods to understand the brain's waste clearance system (the "glymphatic" system) in younger adults. The Investigators hope the study will show how the different brain regions are involved in maintaining memories and how poor sleep affects these regions and our ability to remember.
View original scientific description
This research is being done to apply new, contrast-free MRI (Magnetic Resonance Imaging) methods to understand the brain's waste clearance system (the "glymphatic" system) in younger adults. The Investigators hope the study will show how the different brain regions are involved in maintaining memories and how poor sleep affects these regions and our ability to remember. The Investigators will test whether the Wireless Interface Sensor Pod (WISP) improves brain function after poor sleep. The WISP is a headband that combines tracking brain waves and transcranial electrical stimulation (TES) to monitor and improve slow wave sleep and glymphatic clearance. IParticipants will be asked to: * Complete 4 in-person study visits (1 per week) over 4 weeks at the Diagnostic Imaging Sciences Center (DISC), located at the University of Washington Medical Center at Montlake, Seattle. Each visit will last 2 hours and includes a 1 hour MRI and 1 hour of cognitive testing. * Complete a daily journal about sleep, daily habits, etc. * The night before each of the four study visits, participants will sleep while wearing the WISP headband. * For two of these nights, participants will sleep only 3 hours prior to normal time of awakening. The WISP will deliver a small electrical current for one night and not for the other night, but participants will not know which. * For the other two nights, participants will follow a normal sleep schedule. The WISP will deliver a small electrical current for one night and not for the other night, but participants will not know which.
Interventions
DEVICE
Transcranial Electric Stimulation
Participants will wear the Wireless Interface Sensor Pod (WISP), which combines EEG with Transcranial Electrical Stimulation (TES)
DEVICE
Sham Comparator
Participants will wear the WISP device, but no TES
Primary outcome measures
Multimodal MRI
Time frame: Immediately after the intervention with sleep condition and TES
We will test whether enhancing slow-wave sleep using the AugNOD TES SO improves overnight glymphatic function, as measured by non-invasive multimodal MRI-based markers of glymphatic activity: (i) diffusion-based intravoxel incoherent motion (IVIM)-MRI assessing long-distance water transport (diffusion signal); (ii) fast functional MRI (f-MRI) measuring low-frequency vasomotor oscillations; (iii) T1/FLAIR-based assessment of MRI-visible perivascular spaces (MV-PVS), which serve as structural indicators of perivascular impairment; (iv) multi-echo arterial spin-labeling (ME-ASL)-MRI assessing glial-vascular water transport ; and (v) Magnetic Resonance Elastography (MRE) measuring brain tissue stiffness.
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
- Physically and psychologically healthy
- Good habitual sleep between 6 and 10 hours in duration, as assessed by questionnaire and pre-study week sleep/wake diary
- Regular bedtimes, habitually getting up between 05:00 and 09:00, as assessed by questionnaire and pre-study week sleep/wake diary
Exclusion criteria
- Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction.
- Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
- Subjects who have cerebral aneurysm
- Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
- Minors (younger than 18 years)
- Pregnant women ( Participants of childbearing potential will receive a urine pregnancy test. If the test is positive, the participant will be excluded)
- Breastfeeding
- Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
- no clinical disorders and/or illnesses, no psychiatric illnesses), as assessed by history and questionnaires
- no alcohol during study and no normal excessive alcohol consumption assessed by questionnaire
- No history of drug or alcohol abuse in the past year and no history of methamphetamine abuse, as assessed by questionnaires.
- Not a dependent smoker or vaper, and not morning dependent on tobacco, nicotine, or cannabis, as assessed by questionnaire.
- No history of moderate to severe brain injury, as assessed by questionnaire
- No anti-psychotic medication for ADHD/ADD, as assessed by questionnaire
- No previous adverse reaction to sleep deprivation, as assessed by questionnaire
- Not vision-impaired unless corrected back to normal.
- Not hearing impaired unless corrected to normal, as assessed by questionnaire
- Not pregnant, as assessed by history and questionnaire
- No sleep or circadian disorder, as assessed by questionnaires
- No use of melatonin within 1 week of study enrollment
- No travel across more than one time zone within one month of entering the study and no crossing times zones during study participation, as assessed by questionnaire.
- No shift work within three months of entering the study and no shift work during duration study participation, as assessed by questionnaire.
Where
- Seattle, Washington
Collaborators
Medical Technology Enterprise Consortium
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 May 27, 2026 · Source of record for eligibility and locations