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| ID | Type | Description | Link |
|---|---|---|---|
| S-16-11 | Other Identifier | Sponsor | |
| USAMRDC | Other Identifier | Sponsor |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroConn DC Stimulator PLUS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 11, 12, 13, 14 and 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John D. Hughes, CDR, MC, USN | Contact | 301-319-9350 | john.d.hughes4.ctr@mail.mil | |
| Thomas J Balkin, Ph.D. | Contact | 301-319-9350 | thomas.j.balkin.ctr@mail.mil |
| Name | Affiliation | Role |
|---|---|---|
| John D. Hughes, CDR, MC, USN | Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medcical Research Center (NMRC) Clincal Trials Center | Recruiting | Bethesda | Maryland | 20889-5607 | United States |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| SHAM TES | Device | 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. |
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| 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. | 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). | 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. | 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). | 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. | 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |