Sleep and Brain Clearance Test with a Wireless Sleep-Boosting Headband

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use new contrast-free MRI methods to study how the brain’s waste clearance system, the glymphatic system, works during sleep and how it relates to memory in younger adults. Participants will complete four in-person visits over four weeks, including MRI scans and cognitive testing, while wearing a wireless headband called AugNOD that combines EEG monitoring with transcranial electrical stimulation to promote slow-wave sleep. The study compares real stimulation to a sham condition to see if AugNOD can enhance glymphatic clearance and cognitive performance after sleep disruption. Eligible volunteers are healthy adults with regular sleep schedules and no MRI implants or other contraindications. The trial is led by the University of Washington with support from Medical Technology Enterprise Consortium.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Physically and psychologically healthy
2. Good habitual sleep between 6 and 10 hours in duration, as assessed by questionnaire and pre-study week sleep/wake diary
3. 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.
* epilepsy

Where it's running

• University of Washington School of Medicine
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Iliff, PhD — University of Washington
• Study coordinator: Yeilim Cho, MD
• Email: ycho7@uw.edu
• Phone: (206) 277-7207

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.