Sleep and Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial Electric Stimulation
DeviceParticipants will wear the Wireless Interface Sensor Pod (WISP), which combines EEG with Transcranial Electrical Stimulation (TES)
Sham Comparator
DeviceParticipants will wear the WISP device, but no TES
Treatment groups
16 Participants
are divided into 4 treatment groupsGroup A: Sleep restriction, no TESSham comparator 1 intervention
Group B: Sleep restriction, TESExperimental treatment 1 intervention
Group C: Normal sleep, no TESSham comparator 1 intervention
Group D: Normal sleep, TESExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Immediately after the intervention with sleep condition and TESSecondary outcomes
1
Psychomotor Vigilance Task (PVT)
The PVT is a test of sustained attention, measuring the speed at which individuals respond to visual stimuli. The test requires participants to rapidly respond to visual cues presented within specified interstimulus intervals. Participants are asked to press a button as soon as they see a light appear on a screen, with the light turning on at random intervals, Response times are recorded and evaluated.
Time frame
Immediately after the intervention with sleep condition and TES2
Go/no go task
A decision-making task that requires a participant to respond or withhold a response based on feedback from the computer using arrows or numbers as cues. Number of errors are recorded.
Time frame
Immediately after the intervention with sleep condition and TES3
The Digit Symbol Substitution Test (DSST)
A brief timed coding task (typically 90-120 seconds) in which people use a key to pair digits with symbols and produce as many correct matches as possible. Number of errors will be recorded
Time frame
Immediately after the intervention with sleep condition and TES4
Digit Span
Participants are asked to recall sequences of numbers in order. The longest sequence will be measured.
Time frame
Immediately after the intervention with sleep condition and TESSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Medical Technology Enterprise Consortium
Collaborator
Source ClinicalTrials.gov