Enhancing Slow Wave Sleep in Depression

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Duration of Stage N3 Sleep [Срок оценки: From baseline to week 3]
• Percentage of N3 Sleep [Срок оценки: From baseline to week 3]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• Ability to complete overnight sleep study including placement of EEG leads
• Ability to read and understand English.
• Moderate depression
• Self-reported cognitive complaints

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Публикации

• 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

Идентификаторы

NCT: NCT07143838 · IRB00134801

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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