Depression - Major Depressive DisorderNCT07143838
Enhancing Slow Wave Sleep in Depression
A study testing Transcranial Electrical Stimulation (TES) in people with Depression - Major Depressive Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Transcranial Electrical Stimulation (TES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to complete overnight sleep study including placement of EEG leads
- Ability to read and understand English.
- Moderate depression
- Self-reported cognitive complaints
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104
Ruth Benca, MD PhD, 336-716-2911, ruth.benca@advocatehealth.org
Caitlin Carroll, PhD, 336-716-2440, caitlin.carroll@advocatehealth.org
About this study
Official title: Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression
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.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Transcranial Electrical Stimulation (TES)
- Keywords
- Sleep, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical Stimulation (TES)Device
Also called Sleep WISP (Wireless Interface Sensor Pod)
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Electrical Stimulation (TES) | Experimental | All participants will receive transcranial electrical stimulation (TES) during sleep Receives: Device: Transcranial Electrical Stimulation (TES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Stage N3 Sleep
Change in number of minutes of stage N3 sleep across the night
Measured: From baseline to week 3
Percentage of N3 Sleep
Change in percentage of stage N3 sleep across the night relative to total sleep time
Measured: From baseline to week 3
Secondary outcomes (8)
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.
Measured: Baseline, week 2, week 3
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.
Measured: Baseline, week 2, week 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.
Measured: Baseline, week 2, week 3
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.
Measured: Baseline, week 2, week 3
Trail Making Test B (TMT-B)
TMT-B assesses cognitive flexibility, the ability to switch between different mental sets (in this case, numbers and letters). It also evaluates visual scanning and attention. The test taker is given a sheet of paper with 25 circles, each containing a number (1-13) or a letter (A-L). They must draw a line connecting the circles in ascending order, alternating between numbers and letters (1-A-2-B, and so on). The primary score is the time it takes to complete the task (0-300 seconds). Longer duration to complete indicates greater impairment in cognitive flexibility and attention.
Measured: Baseline, week 2, week 3
Perceived Deficits Questionnaire 5 (PDQ-5)
5-item questionnaire with total score range 0-20. Higher score indicates greater perceived deficit.
Measured: Baseline, week 2, week 3
Center for Epidemiologic Studies Depression Scale (CES-D)
20 items with total score range 0-60. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, week 2, week 3
Patient Health Questionnaire (PHQ-9)
9 items with total score range 0-27. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, week 2, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start4 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Benca, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143838
- Sponsor's protocol ID
- IRB00134801
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 33812203Peterson 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.
PubMed 17118279Benca 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.
PubMed 1386215
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression
- ClinicalTrials.gov ID
- NCT07143838
- Acronym / sponsor ID
- IRB00134801
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Sleep, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Electrical Stimulation (TES) | Experimental | Device: Transcranial Electrical Stimulation (TES)All participants will receive transcranial electrical stimulation (TES) during sleep |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to complete overnight sleep study including placement of EEG leads
- Ability to read and understand English.
- Moderate depression
- Self-reported cognitive complaints
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Electrical Stimulation (TES)Also: Sleep WISP (Wireless Interface Sensor Pod)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. | Device | Transcranial Electrical Stimulation (TES) |
Primary outcome
Duration of Stage N3 Sleep
Time frame: From baseline to week 3
Change in number of minutes of stage N3 sleep across the night
Percentage of N3 Sleep
Time frame: From baseline to week 3
Change in percentage of stage N3 sleep across the night relative to total sleep time
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 33812203Hathaway 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.
- Background: PubMed 17118279Peterson 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.
- Background: PubMed 1386215Benca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth Benca, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Electrical Stimulation (TES) in people with Depression - Major Depressive Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Benca, MD, PhD (336-716-2911, ruth.benca@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Stage N3 Sleep (time frame: From baseline to week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.