NCT07143838 · Wake Forest University Health Sciences
Enhancing Slow Wave Sleep in Depression
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Transcranial 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.
Primary outcome measures
Duration of Stage N3 Sleep
Time frame: From baseline to week 3
Change in number of minutes of stage N3 sleep across the night
Percentage of N3 Sleep
Time frame: From baseline to week 3
Change in percentage of stage N3 sleep across the night relative to total sleep time
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations