Enhancing Slow Wave Sleep in Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Transcranial Electrical Stimulation (TES)

    Device

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Transcranial Electrical Stimulation (TES)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of Stage N3 Sleep

Change in number of minutes of stage N3 sleep across the night

Time frame
From baseline to week 3
2

Percentage of N3 Sleep

Change in percentage of stage N3 sleep across the night relative to total sleep time

Time frame
From baseline to week 3

Secondary outcomes

1

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.

Time frame
Baseline, week 2, week 3
2

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.

Time frame
Baseline, week 2, week 3
3

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.

Time frame
Baseline, week 2, week 3
4

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.

Time frame
Baseline, week 2, week 3

Other outcomes

1

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.

Time frame
Baseline, Week 3
2

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.

Time frame
Baseline, Week 3
3

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.

Time frame
Baseline

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