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

NCT ID: NCT03879044

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2020-06-20

Brief Summary

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.

Detailed Description

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.

Conditions

Shift-Work Sleep Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial Direct Current Stimulation

Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.

Interventions

Transcranial Direct Current Stimulation

tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.

Intervention Type: DEVICE

Other Intervention Names

tDCS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ulysses Magalang MD

Professor of Medicine and Neuroscience Director, Sleep Medicine Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulysses Magalang, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018H0139

Identifier Type: -

Identifier Source: org_study_id