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Tracy Jill Doty, Ph.D.
Chief, Sleep Research Center
Behavioral Biology Branch
Walter Reed Army Institute of Research
503 Robert Grant Avenue
Silver Spring, Maryland 20910
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Study Title:
Transcranial Electrical Stimulation at Slow Oscillation Frequency during NREM Sleep: An Assessment of Effects on the Restorative Properties of Sleep
What is this study about?
The goal of the study is to determine if stimulating the brain using very weak electrical currents, during a period of sleep, will help people feel more refreshed and alert during the day.
Requirements to participate:
You must meet ALL of the following criteria to be eligible for the study:
ü You must be between 18 and 39 years old
ü You must be in good general health
ü You must have learned English as your first language
ü You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)
ü You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder
ü You must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule
ü You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
ü You must not be on certain medications (determined on a case by case basis)
ü You must test negative for illicit drugs
ü Women must not be pregnant or nursing
ü You must not be participating in another ongoing clinical trial
ü You must have a social security number or tax identification number in order to be paid for screening and participation in the study
You also cannot have a history of the following conditions:
· Cardiovascular disease
· A neurologic disorder
· Pulmonary disease requiring inhaler use
· Kidney disease or kidney abnormalities
· Liver disease of liver abnormalities
· A history of a psychiatric disorder requiring hospitalization or medication within the last two years
First Step - Screening visit:
· 2-3 hour visit to determine if you are eligible to participate
· Located at Walter Reed Army Institute of Research in Silver Spring, MD
· Review study information and read and sign the study consent form
· Complete short assessments and questionnaires
· Brief medical assessment and medical history
· Provide urine, saliva, and blood samples to test for general health and the presence of prohibited substances, and pregnancy is female
· Compensation for screening is $25.00 whether or not are eligible for the study
How long is the study?
The study is 15 consecutive days long. If eligible based on your screening visit, you have 90 days to participate in a 15 day study session. More details about the 15 day session are below.
Study schedule requirements:
Day 1: This is approximately a 2 hour visit. You will complete several questionnaires, provide urine and saliva samples, and receive a wrist-worn device called an actigraph to wear continuously for the next 7 days. During these 7 days you will follow your regular schedule at home.
Days 8-10: You will sleep overnight at the lab for three consecutive nights. On these evenings you arrive at 6:00pm and leave in the mornings at approximately 8:00am. After the first two nights, you will be allowed to leave during the day and go about your normal business. After the third night, you will remain in the lab for the next five days full time. You will also provide urine and saliva samples on a daily basis.
Days 11-15: This part requires a five full night stay in the sleep lab. You will perform computerized tests and complete pencil/paper tasks on a schedule. When you are not testing you are free to do personal activities in the lounge area, but please note that hand held electronic devices such a cell phones and laptop are not allowed during the five day lab stay. The first night of this part of the study, you will only spend approximately 2 hours in bed where you may or may not receive stimulation with a weak electrical current. There is a placebo group for the study, and so you will not know if you are receiving the stimulation of not. Upon awakening after the 2 hour period, you will remain awake for 46 hours and continue to perform tasks. After the 46 hour period with no sleep, you will then the next two days in the lab for recovery and you are able to sleep for 8 hours per night. On the last day, you will continue to complete tasks and prior to release from the study a study medical investigator will give you a brief physical assessment.
If you are a federal employee (active duty or civilian) you will need to be on leave or off duty for in-laboratory portion, and if you are in the military you must have your Supervisor’s approval to participate in the study.
Compensation for participation:
If your complete all parts of the study you will be paid $2,237.00 plus an additional $500 bonus if all portions of the study are completed successfully. The maximum total amount that you could be paid, including the screening payment, is $2,737.00.
NOTE: Participation is always voluntary. If you come in for the screening visit, you are not obligated to go through the entire screening visit or participate in the study. You can change your mind about participating at any time.
To learn more about this study or schedule a screening appointment, please contact the WRAIR Sleep Research Center
Phone: 301-319-9287 (Monday-Friday 9:00am – 5:00pm)
E-mail: usarmy.detrick.medcom-wrai...@mail.mil