Enhancing Slow Wave Sleep in Depression

Official title

Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression

Overview

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.

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 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.

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]
• Percentage of N3 Sleep [Time frame: From baseline to week 3]

Secondary outcome measures (8)

• Word Pairs Memory Task [Time frame: Baseline, week 2, week 3]
• Choice Reaction Time (CRT) [Time frame: Baseline, week 2, week 3]
• Digit Symbol Substitution Test (DSST) [Time frame: Baseline, week 2, week 3]
• One-Back Working Memory Test [Time frame: Baseline, week 2, week 3]
• Trail Making Test B (TMT-B) [Time frame: Baseline, week 2, week 3]
• Perceived Deficits Questionnaire 5 (PDQ-5) [Time frame: Baseline, week 2, week 3]
• Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: Baseline, week 2, week 3]
• Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, week 2, week 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Publications

• 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 33812203
• Peterson 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 17118279
• Benca 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 1386215

Identifiers

NCT: NCT07143838 · IRB00134801

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗