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

NCT03879044 | Terminated Results DMC FDA Device

• 1 other identifier: 2018H0139
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shift-Work Sleep Disorder

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (2)

• Psychomotor Vigilance Test

  Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.

  3 minutes

• Karolinska Sleepiness Scale

  Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.

  5 minutes

Secondary Outcomes (1)

• Epworth Sleepiness Scale

  5 minutes

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation 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.

Also known as: tDCS

Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Outcome measurements and adverse events were not analyzed and reported as the study was terminated due to funding stopped

Results Point of Contact

• Title: Dr. Ulysses Magalang
• Organization: The Ohio State University Wexner Medical Center

Ulysses.Magalang@osumc.edu

614-292- 4307

Study Officials

• Ulysses Magalang, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Neuroscience Director, Sleep Medicine Program

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: March 20, 2019
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)