Enhancing Slow Wave Sleep in Depression
Recruiting · NCT07143838 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 is running
1 location listed across 1 US state.
- Wake Forest University Health Sciences - Winston-Salem, North Carolina, United States