Enhancing Slow Wave Sleep in Depression

Wake Forest University (WFU)

Status

Not yet enrolling

Conditions

Depression - Major Depressive Disorder

Treatments

Device: Transcranial Electrical Stimulation (TES)

Study type

Interventional

Funder types

Other

Identifiers

NCT07143838

IRB00134801

Details and patient eligibility

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.

Full 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 depression. Individuals with depression frequently report sleep and cognitive disturbances as symptoms associated with their depression. However, common anti-depressants often fail to improve these symptoms. A pilot study with this device showed that TES can enhance slow wave sleep in healthy individuals. This study aims to evaluate if TES will enhance deep sleep in individuals with depression as well, leading to improved sleep outcomes and potentially improving cognitive performance and mood symptoms.

This study proposes to conduct using the Sleep WISP device (Brain Electrophysiology Laboratory (BEL), Eugene, OR). Using this non-invasive device, the study will record brain activity using a technique called electroencephalography (EEG) that will be automatically scored in real-time to determine the stage of sleep. After the participant enters stable slow wave sleep, the headband will deliver the TES current (0.5-1 milliampere (mA) total) directly to the scalp through pre-set electrodes. The stimulation will be applied for 5 cycles of 5 minutes of stimulation, 1 minute of no stimulation (30 minutes total). This level and location of stimulation was previously shown as sufficient to increase SWS.

After screening and enrolling in the study, participants will have up to three nights of baseline recordings using the WISP headband to ensure successful baseline measurements are recorded. Participants will then receive TES nightly for two weeks. Participants will also wear an actigraphy watch and keep a sleep diary throughout the duration of the study. Finally, participants will complete several cognitive assessments and sleep and mood questionnaires throughout the duration of the study.

Enrollment

12 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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