Enhancing Slow Wave Sleep in Depression
Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression
1 other identifier
interventional
12
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 24, 2026
July 1, 2025
7 months
August 18, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of Stage N3 Sleep
Change in number of minutes of stage N3 sleep across the night
From baseline to week 3
Percentage of N3 Sleep
Change in percentage of stage N3 sleep across the night relative to total sleep time
From baseline to week 3
Secondary Outcomes (8)
Word Pairs Memory Task
Baseline, week 2, week 3
Choice Reaction Time (CRT)
Baseline, week 2, week 3
Digit Symbol Substitution Test (DSST)
Baseline, week 2, week 3
One-Back Working Memory Test
Baseline, week 2, week 3
Trail Making Test B (TMT-B)
Baseline, week 2, week 3
- +3 more secondary outcomes
Other Outcomes (3)
Epworth Sleepiness Scale
Baseline, Week 3
Pittsburgh Sleep Quality Index
Baseline, Week 3
Morningness-Eveningness Questionnaire
Baseline
Study Arms (1)
Transcranial Electrical Stimulation (TES)
EXPERIMENTALAll participants will receive transcranial electrical stimulation (TES) during sleep
Interventions
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.
Eligibility Criteria
You may qualify if:
- Ability to complete overnight sleep study including placement of EEG leads
- Ability to read and understand English.
- Moderate depression
- Self-reported cognitive complaints
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Related Publications (3)
Hathaway E, Morgan K, Carson M, Shusterman R, Fernandez-Corazza M, Luu P, Tucker DM. Transcranial Electrical Stimulation targeting limbic cortex increases the duration of human deep sleep. Sleep Med. 2021 May;81:350-357. doi: 10.1016/j.sleep.2021.03.001. Epub 2021 Mar 8.
PMID: 33812203BACKGROUNDPeterson MJ, Benca RM. Sleep in mood disorders. Psychiatr Clin North Am. 2006 Dec;29(4):1009-32; abstract ix. doi: 10.1016/j.psc.2006.09.003.
PMID: 17118279BACKGROUNDBenca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. doi: 10.1001/archpsyc.1992.01820080059010.
PMID: 1386215BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Benca, MD, PhD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2025
First Posted
August 27, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 24, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share