RecruitingNot ApplicableNCT07143838

Enhancing Slow Wave Sleep in Depression

Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression


Sponsor

Wake Forest University Health Sciences

Enrollment

12 participants

Start Date

Jun 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this pilot study is to determine if non-invasive brain stimulation during sleep can increase deep sleep in adults with depression. It will also determine if increased deep sleep improves cognitive performance and mood ratings. Participants will be asked to wear a non-invasive device that records their brain activity and delivers transcranial electrical stimulation during sleep. Participants will also wear an actigraphy watch that measures activity levels throughout the study. In addition, participants will complete several cognitive assessments and mood and sleep questionnaires throughout the study.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria4

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

Exclusion Criteria13

  • 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

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Interventions

DEVICETranscranial Electrical Stimulation (TES)

Using the Sleep WISP device, transcranial electrical stimulation will be delivered during sleep as 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.


Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT07143838


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