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Behavioural Intervention
NeuroConn DC Stimulator PLUS for Sleep Deprivation
N/A
Recruiting
Led By John D. Hughes, CDR, MC, USN
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 11, 12, 13, 14 and 15
Awards & highlights
Summary
This trial will test whether a brain stimulation technique can help people sleep better and perform better when sleep-deprived.
Eligible Conditions
- Sleep Deprivation
- Mental Competency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 11, 12, 13, 14 and 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 11, 12, 13, 14 and 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Point of care safety
Secondary outcome measures
Measure alertness using the Karolinska Sleepiness Scale (KSS)
Measure current mood states using the Mood Analogue Scale (MAS)
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects Who Received TES SOExperimental Treatment1 Intervention
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.
Group II: Received SHAM (no TES SO)Placebo Group1 Intervention
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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Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
288 Previous Clinical Trials
245,989 Total Patients Enrolled
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,734 Total Patients Enrolled
3 Trials studying Sleep Deprivation
146 Patients Enrolled for Sleep Deprivation
John D. Hughes, CDR, MC, USNPrincipal InvestigatorNaval Medical Research Center
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