Enhancing Deep Sleep in Depression with Non-Invasive Brain Stimulation

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

This pilot study investigates whether transcranial electrical stimulation delivered during slow-wave sleep can boost deep sleep in adults with depression. EEG-based real-time sleep staging guides stimulation, applied as 0.5-1 mA for five 5-minute blocks with brief breaks. Participants wear an actigraphy device and complete cognitive and mood questionnaires to assess potential sleep, cognitive, and mood benefits. The study uses the Sleep WISP device to deliver stimulation and record data during overnight sessions at Wake Forest University Health Sciences. Outcomes will inform whether enhanced deep sleep translates to improved cognitive performance and mood symptoms in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to complete overnight sleep study including placement of EEG leads
* Ability to read and understand English.
* Moderate depression
* Self-reported cognitive complaints

Exclusion Criteria:

* Previous adverse reaction to transcranial electrical stimulation
* Presence of implanted devices (e.g. intracranial device, cochlear implant)
* Presence of metal in head (e.g. surgical clip)
* Sensitivity or allergy to silver
* Presence of significant neurologic disease (e.g. Parkinson's disease, epilepsy/seizure disorder, severe migraine disorder)
* History of significant head trauma
* History of stroke or other ischemic event
* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation
* Currently taking medications that could alter EEG or cognitive function
* Presence of severe insomnia
* Presence of severe, untreated sleep apnea
* Currently pregnant
* Planned travel outside time zone during the study

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ruth Benca, MD, PhD — Wake Forest University Health Sciences
• Study coordinator: Ruth Benca, MD, PhD
• Email: ruth.benca@advocatehealth.org
• Phone: 336-716-2911

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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.