Status:

NOT_YET_RECRUITING

Enhancing Slow Wave Sleep in Depression

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

Depression - Major Depressive Disorder

Eligibility:

All Genders

40-80 years

Phase:

NA

Brief 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 c...

Detailed Description

The purpose of this pilot study is to determine if non-invasive transcranial electrical stimulation (TES) delivered during slow-wave sleep (SWS) can enhance this stage of sleep in people with depressi...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT07143838

Start Date

January 1 2026

End Date

December 1 2026

Last Update

December 17 2025

Active Locations (1)

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27104