Sleep DeprivationNCT02945501
Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep
A study testing NeuroConn DC Stimulator PLUS in people with Sleep Deprivation and Mental Competency, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Mental Competency
- What is being tested?
- NeuroConn DC Stimulator PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2016to Dec 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.
Who cannot join
- Self-reported habitual nightly sleep amounts outside the target range of 6 - 9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)
- Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) or later than 2300. (Post-consent Checklist)
- Self-reported morning wake-up times later than 0800 on average during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 1 time a week in conjunction with normal sleep habits) (Post-consent Checklist)
- A rating of 6 or below on question 2 or 3 of the Nonrestorative Sleep Scale, indicating the subject experiences relatively non-refreshing sleep
- An average time to sleep onset of greater than 20 minutes as indicated on the Post-consent Checklist
Show all 35Show fewer
- Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or 4 12-oz cups of coffee) per day on average (Post-consent Checklist; document provides exclusionary limits for various caffeinated products).
- Score of lower than 31 or higher than 69 on the Morningness-Eveningness Questionnaire (MEQ form)
- Score of 14 or above on the Beck Inventory Form (BDI form)
- Score of 41 or above on the Self-Evaluation Questionnaire
- History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction) (Medical History and Examination Form)
- History of neurologic disorder (to include, but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders) (Medical History and Examination form; sleep items on Post-Consent Checklist)
- Underlying pulmonary disease requiring daily inhaler use (Medical History and Examination form)
- Kidney disease or kidney abnormalities (Medical History and Examination form, laboratory results)
- Liver disease or liver abnormalities (Medical History and Examination form, laboratory results)
- Self-reported history of psychiatric disorder requiring hospitalization or psychiatric product within the last 2 years or for more than 3 months at one time. (Medical History and Examination form)
- Self-reported or suspected regular nicotine use or addiction, defined as more than 1 cigarette or equivalent per week, within the last 1 year (Medical History and Examination form)
- Self-reported or suspected heavy alcohol use; minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining appropriately licensed study investigator (Medical History and Examination form)
- Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining appropriately licensed study investigator (Medical History and Examination form)
- Self-reported or suspected current use of other illicit drugs, to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana (Medical History and Examination form)
- Positive urine pregnancy result
- Resting blood pressure above 140/90 or resting pulse > 110 (Medical History and Examination form). Note that if a repeat measurement is within range then the volunteer will not be excluded.
- BMI ≥ 30 (Obese Class I or greater) (Medical History and Examination form)
- Clinically significant values (as determined by the appropriately licensed study investigator reviewing the study) for any hematology or chemistry parameter. The appropriately licensed study investigator reviewing the laboratory values may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.
- Positive urine nicotine/cotinine result during screening visit (NicCheck™ I test strip results)
- Positive urine drug result during screening visit
- Any use of sleep aids during the 1 year prior to screening
- Inability to read and sign consent
- Lack of access to a quiet, dark environment conducive to sleep from 2100 until 0700 during a seven night period at the beginning of the study
- Participation in any ongoing clinical trials.
- The preceding exclusionary criteria are known to alter sleep (e.g., epilepsy; some neurological disorders), substantially increase inter-subject variability, and/or the disease or condition puts the subject outside the range of what is considered healthy. The PI also maintains the prerogative to disqualify a volunteer if it is deemed that the volunteer's participation would be unsafe for the volunteer or staff or would be disruptive to study conduct or their inclusion could compromise data integrity.
- Volunteers meeting the Beck cut-off (a score of at least 14) and who carry health insurance will be instructed to call their health insurance Mental Health / Substance Abuse referral number.
- Volunteers meeting the first cut-off (score of at least 14 who are not insured will be provided with a community mental health referral contact specific to their county of residence.
- The review of the medical history with the volunteer and the physical examination itself will be performed by an appropriately licensed study investigator. Results of screening urine and blood tests will be reviewed by an appropriately licensed study investigator. The Post-consent Checklist will be administered by a trained research technician and reviewed by the study principal investigator or an appropriately licensed study investigator. If an appropriately licensed study investigator deems it medically advisable, the investigator will share abnormal results with the volunteer, who will be referred to his/her personal physician for follow-up.
- A volunteer who has been cleared for participation may participate in a session if the first day of the session is within 90 days of the screening date. If the first day of the study session is 91 or more days since the volunteer has been screened, the volunteer must re-screen to ensure there has not been a change in eligibility status.
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
Naval Medcical Research Center (NMRC) Clincal Trials Center
Bethesda, Maryland, 20889-5607
John D. Hughes, CDR, MC, USN, 301-319-9350, john.d.hughes4.ctr@mail.mil
About this study
Official title: Transcranial Electrical Stimulation at Slow Oscillation Frequency During NREM Sleep: An Assessment of Effects on the Restorative Properties of Sleep
The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves performance during a subsequent period of sleep deprivation.
Read the detailed description
40 subjects will be enrolled and randomized to participate in this study. A 60 minute TES stimulation sequence consisting of a SO frequency stimulation (TES SO) using the NeuroConn DC Stimulator PLUS or a sham stimulation will be administered during the second hour of a two hour nocturnal sleep period. During wake period subjects will be tested using various cognitive, subjective and objective sleepiness and mood measures. Vital signs measurements will be taken to monitor general health issues. Up to 4 subjects will be enrolled per study session. Due to logistical reasons, no more then 2 subjects per session can be assigned to the TES SO group.
Screening visit = approx. 2 hours At-home component = 7 days In-laboratory study period = 138 hours Total in-laboratory period = approx. 138 hours per subject Total participation time (at home + in-laboratory components) = 15 days
- Conditions
- Sleep Deprivation, Mental Competency
- Being tested
- NeuroConn DC Stimulator PLUS, SHAM TES
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroConn DC Stimulator PLUSDevice
Prior to bedtime on the sleep restriction night, 4 transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will receive a one hour period of SO stimulation, for a total of approximately two hours of sleep.
SHAM TESDevice
Also called Placebo
Prior to bedtime on the sleep restriction night, 4 placebo transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will sleep for approximately 2 hours without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Who Received TES SO | Experimental | Participants will sleep for approximately a two hour period and receive TES SO via the NeuroConn DC Stimulator PLUS during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment. Receives: Device: NeuroConn DC Stimulator PLUS |
| Received SHAM (no TES SO) | Sham comparator | Participants will sleep for approximately a two hour period and receive a SHAM (no TES SO) during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment. Receives: Device: SHAM TES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point of care safety
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. Vital signs (blood pressure, pulse, and temperature) will be recorded and abnormal values will be reported to PI who will determine if events meet criteria and definition of an unanticipated device effect (UADE).
Measured: Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study
Secondary outcomes (6)
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Performed at approximately 75 minutes intervals throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on night of sleep restriction.
Measured: Days 11, 12, 13, 14 and 15
Measure the efficiency and accuracy of simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Computer based series of mathematical calculations consisting of 3 single digit numbers (e.g. 3+4-5) and indicate if the value of the answer is less than or greater than 5.
Measured: Performed at approximately 75 minute intervals throughout waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day. Days 11 - 15
Measure current mood states using the Mood Analogue Scale (MAS)
Computer based self adjective checklist to measure mood states along six subscales: tension-anxiety, anger-hostility, depression-dejection, vigor-activity, fatigue-inertia, and confusion-bewilderment. Adjectives are rated on a scale 1 (not at all) to 6 (extremely).
Measured: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
Subjects will be escorted to their individual darkened, sound-attenuated bedrooms and allowed to lie down on their beds. They will be instructed to close their eyes and try to remain awake. Polysomnography will be monitored online.
Measured: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Computer based self rated level of alertness ranging from 1 (extremely alert to 9 (extremely sleepy).
Measured: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure of declarative or associative learning using the Paired Word Associates Task (PWAT)
46 word pairs will be administered in a learning phase. Four additional word pairs will be administered at the beginning and end of the 46 pair test list during the learning phase in order to minimize primacy and recency learning effects, but will not be part of the recall phase.
Measured: Within 60 minutes of bedtime on the sleep restriction night with a recall phase conducted approximately 20 and 120 minutes after awakening on the same night. Days 11 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start27 Oct 2016
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- John D. Hughes, CDR, MC, USN, Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945501
- Sponsor's protocol ID
- WRAIR 2262
- Other IDs
- S-16-11, USAMRDC
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2016
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation at Slow Oscillation Frequency During NREM Sleep: An Assessment of Effects on the Restorative Properties of Sleep
- ClinicalTrials.gov ID
- NCT02945501
- Acronym / sponsor ID
- WRAIR 2262
- Conditions
- Sleep Deprivation, Mental Competency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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 purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves performance during a subsequent period of sleep deprivation.
Detailed description
40 subjects will be enrolled and randomized to participate in this study. A 60 minute TES stimulation sequence consisting of a SO frequency stimulation (TES SO) using the NeuroConn DC Stimulator PLUS or a sham stimulation will be administered during the second hour of a two hour nocturnal sleep period. During wake period subjects will be tested using various cognitive, subjective and objective sleepiness and mood measures. Vital signs measurements will be taken to monitor general health issues. Up to 4 subjects will be enrolled per study session. Due to logistical reasons, no more then 2 subjects per session can be assigned to the TES SO group.
Screening visit = approx. 2 hours At-home component = 7 days In-laboratory study period = 138 hours Total in-laboratory period = approx. 138 hours per subject Total participation time (at home + in-laboratory components) = 15 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Who Received TES SO | Experimental | Device: NeuroConn DC Stimulator PLUSParticipants will sleep for approximately a two hour period and receive TES SO via the NeuroConn DC Stimulator PLUS during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment. |
| Received SHAM (no TES SO) | Sham comparator | Device: SHAM TESParticipants will sleep for approximately a two hour period and receive a SHAM (no TES SO) during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.
Key exclusion criteria (35 listed)
- Self-reported habitual nightly sleep amounts outside the target range of 6 - 9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)
- Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) or later than 2300. (Post-consent Checklist)
- Self-reported morning wake-up times later than 0800 on average during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 1 time a week in conjunction with normal sleep habits) (Post-consent Checklist)
- A rating of 6 or below on question 2 or 3 of the Nonrestorative Sleep Scale, indicating the subject experiences relatively non-refreshing sleep
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 |
|---|---|---|
| NeuroConn DC Stimulator PLUSPrior to bedtime on the sleep restriction night, 4 transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will receive a one hour period of SO stimulation, for a total of approximately two hours of sleep. | Device | Subjects Who Received TES SO |
| SHAM TESAlso: PlaceboPrior to bedtime on the sleep restriction night, 4 placebo transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will sleep for approximately 2 hours without stimulation. | Device | Received SHAM (no TES SO) |
Primary outcome
Point of care safety
Time frame: Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. Vital signs (blood pressure, pulse, and temperature) will be recorded and abnormal values will be reported to PI who will determine if events meet criteria and definition of an unanticipated device effect (UADE).
6 secondary outcomes
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Time frame: Days 11, 12, 13, 14 and 15
Measure the efficiency and accuracy of simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Time frame: Performed at approximately 75 minute intervals throughout waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day. Days 11 - 15
Measure current mood states using the Mood Analogue Scale (MAS)
Time frame: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
Time frame: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Time frame: Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15
Measure of declarative or associative learning using the Paired Word Associates Task (PWAT)
Time frame: Within 60 minutes of bedtime on the sleep restriction night with a recall phase conducted approximately 20 and 120 minutes after awakening on the same night. Days 11 and 12
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 13 Jun 2025.
- 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.
John D. Hughes, CDR, MC, USN principal investigator
Naval Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroConn DC Stimulator PLUS in people with Sleep Deprivation and Mental Competency, run by U.S. Army Medical Research and Development Command 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 2 inclusion and 35 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 13 Jun 2025. 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. Some participants in this study may receive a placebo. 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 John D. Hughes, CDR, MC, USN (301-319-9350, john.d.hughes4.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point of care safety (time frame: Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.