About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to complete overnight sleep study including placement of EEG leads
Ability to read and understand English.
Moderate depression
Self-reported cognitive complaints
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Transcranial Electrical Stimulation (TES)
DeviceUsing 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.
Treatment groups
Trial outcomes
Primary outcomes
Duration of Stage N3 Sleep
Change in number of minutes of stage N3 sleep across the night
Percentage of N3 Sleep
Change in percentage of stage N3 sleep across the night relative to total sleep time
Secondary outcomes
Word Pairs Memory Task
Participants are presented with 44 word-pairs to learn during an encoding phase and immediately tested by presenting one word and being asked to recall the paired word. Participants are tested again in the morning in the same way - one word of the pair is presented and they are asked to recall the other. To avoid recency and priming effects, the first 4 and last 4 word pairs presented are not scored. Participants are scored on accuracy (0-36 words). A smaller decline in accuracy from the immediate recall (evening) to delayed recall phase (morning) indicates better verbal memory performance.
Choice Reaction Time (CRT)
CRT measures the time it takes for a person to respond to a stimulus when there are multiple possible responses to choose from. It is a measure of how quickly someone can process information, make a decision, and initiate a motor response. Participants are presented with 20 trials of stimuli to respond to. The test is scored on average reaction time where a longer reaction time indicates worse processing speed performance.
Digit Symbol Substitution Test (DSST)
133-item neuropsychological assessment that measures cognitive functions like processing speed, attention, and visuoperceptual skills. It involves matching symbols to numbers based on a provided key and is often used to assess cognitive impairment. The number of correct symbols within 120 seconds constitutes the score (0-133 max score) where a lower score represents greater impairment in processing speed and attention.
One-Back Working Memory Test
Cognitive test that assesses an individual's ability to hold and manipulate information in their short-term memory. The one-back working memory test is scored by assessing both accuracy and average response time. Accuracy is measured as the percentage of correct responses (hits) to target stimuli, while response time reflects the average speed at which participants identify matches. Higher accuracy and faster response times generally indicate better working memory performance. Participants are presented with 20 total trials (potential accuracy score, 0-20; potential reaction time 0-3 seconds). Both the accuracy and reaction time scores are z-scored and then combined to create a single composite score for the test.
Other outcomes
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is an 8-item self-administered questionnaire to assess an individual's level of daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. A score of 10 or higher generally suggests excessive daytime sleepiness, possibly indicating a sleep disorder.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess sleep quality and disturbances over a one-month period. Scores range from 0-21, where a higher score indicates more severe sleep disturbance. Generally, a global score of greater than 5 indicates poor sleep quality.
Morningness-Eveningness Questionnaire
The Morningness-Eveningness Questionnaire (MEQ) is a 19-item subjective assessment designed to assess individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day. The MEQ is scored by summing the responses to 19 questions, with each question offering multiple choice answers that are assigned numerical values. Scores range from 16 to 86, with lower scores indicating an "evening" chronotype and higher scores indicating a "morning" chronotype.
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