Sleep and Performance

NCT07608614 | Recruiting FDA Device

• 2 other identifiers: STUDY00021849W81XWH-21-09-0021-129
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Glymphatic System

Keywords

sleep; glymphatic system; cognitive function

Outcome Measures

Primary Outcomes (1)

• Multimodal MRI

  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.

  Immediately after the intervention with sleep condition and TES

Secondary Outcomes (5)

• Psychomotor Vigilance Task (PVT)

  Immediately after the intervention with sleep condition and TES

• Go/no go task

  Immediately after the intervention with sleep condition and TES

• The Digit Symbol Substitution Test (DSST)

  Immediately after the intervention with sleep condition and TES

• Digit Span

  Immediately after the intervention with sleep condition and TES

• Positive and Negative Affect Schedule (PANAS)

  Immediately after the intervention with sleep condition and TES

Study Arms (4)

Sleep restriction, no TES

SHAM COMPARATOR

Participants will have sleep restriction, sham TES

Device: Sham Comparator

Sleep restriction, TES

EXPERIMENTAL

Participants will have sleep restriction, will have active TES

Device: Transcranial Electric Stimulation

Normal sleep, no TES

SHAM COMPARATOR

Participants will follow normal sleep schedule, sham TES

Device: Sham Comparator

Normal sleep, TES

EXPERIMENTAL

Participants will follow normal sleep schedule, will have TES

Device: Transcranial Electric Stimulation

Interventions

Transcranial Electric Stimulation DEVICE

Participants will wear the Wireless Interface Sensor Pod (WISP), which combines EEG with Transcranial Electrical Stimulation (TES)

Normal sleep, TES; Sleep restriction, TES

Sham Comparator DEVICE

Participants will wear the WISP device, but no TES

Normal sleep, no TES; Sleep restriction, no TES

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Medical Technology Enterprise Consortium: collaborator

Study Sites (1)

University of Washington School of Medicine

Seattle, Washington, 98125, United States

RECRUITING

Study Officials

• Jeffrey Iliff, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeilim Cho, MD

CONTACT

(206) 277-7207; ycho7@uw.edu

Maria Tsimpanouli

CONTACT

tiats@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, UW Department of Psychiatry and Behavioral Sciences/UW Department of Neurology

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

US (1)