Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:3/20/2019
Start Date:March 20, 2019
End Date:March 19, 2021
Contact:Samantha Rojas, BA
Email:samantha.rojas@osumc.edu
Phone:614-366-2361

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1. To determine the effects of tDCS on subjective measures of sleepiness in night-shift
workers with shift work disorder.

2. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance
in night-shift workers with shift work disorder.

This is a preliminary single-arm study. The study will last up to 6 weeks including the
screening period. Subjects will receive active tDCS for 30 minutes before their scheduled
work hours at least 3x/week for two consecutive weeks.

Outcome measures will include: psychomotor vigilance test (PVT) and the Karolinska Sleepiness
Scale (KSS)25,26 which will be obtained during the shift work.

Inclusion Criteria:

- age 18-65 years

- works 5 or more night shifts per month (each shift lasting at least 10 hours, with ≥6
hours worked between 10 pm and 8 am) with plans to maintain this schedule for the
duration of the 3-week trial

- meets the criteria for Shift Work Disorder according to the International
Classification of Sleep Disorders24 and evaluation of a sleep medicine provider
(physician or nurse practitioner) during a screening evaluation:

1. affirmative answers to Do you experience excessive sleepiness? (yes/no); "Do you
experience difficulties with falling asleep during opportunities for sleep?
(yes/no); "Is the sleep or sleepiness problem related to a work schedule where
you have to work when you would normally sleep? (yes/no)"; and "Has this sleep or
sleepiness problem related to your work schedule persisted for at least three
months? (yes/no)

2. based on the evaluation of the sleep medicine provider, the sleep and/or wake
disturbance are not better explained by another current sleep disorder, medical
or neurologic disorder, mental disorder, medication use, poor sleep hygiene, or
substance abuse disorder.

- Stable medication dosage over previous 4 weeks.

- Able to understand English and give a written informed consent document.

Exclusion Criteria:

- Currently taking stimulant medications such as Modafinil, Armodafinil,
Methylphenidate, or Dextroamphetamine.

- History of automobile accident due to falling asleep while driving

- Inability to understand or read English

- Self-reported Substance abuse (current)

- Excessive alcohol consumption defined as:

- More than 3 glasses of wine a day

- More than 3 beers a day

- More than 60 mL of hard liquor a day

- Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator
(AICD).

- Pregnancy, lactation (will be screened with urine pregnancy test)

- Non-removable metal or tattoos around head

- Use of implantable birth control device such as Implanon

- History of frequent severe headaches

- Unstable coronary artery disease

- Uncontrolled Seizure disorder

- Uncontrolled hypertension

- Any other clinically significant condition that, in the opinion of the Investigator,
might put the subject at risk of harm during the study or might adversely affect the
interpretation of the study data.
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 611-366-2361
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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