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

• Sponsor: Ohio State University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03879044
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shift-Work Sleep Disorder	Device: Transcranial Direct Current Stimulation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)
• Actual Study Start Date: Mar 20, 2019
• Actual Primary Completion Date: Jun 20, 2020
• Actual Study Completion Date: Jun 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcranial Direct Current Stimulation Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.	Device: 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.; Other Names: tDCS

Outcome Measures

Primary Outcome Measures

1. Psychomotor Vigilance Test [3 minutes]

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

2. Karolinska Sleepiness Scale [5 minutes]

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

Secondary Outcome Measures

1. Epworth Sleepiness Scale [5 minutes]

   Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Ulysses Magalang, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 7, 2018
• Informed Consent Form - Jul 9, 2018

More Information

Publications

None provided.

• Responsible Party: Ulysses Magalang MD, Professor of Medicine and Neuroscience Director, Sleep Medicine Program, Ohio State University
• ClinicalTrials.gov Identifier: NCT03879044
• Other Study ID Numbers: 2018H0139
• First Posted: Mar 18, 2019
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ulysses Magalang MD, Professor of Medicine and Neuroscience Director, Sleep Medicine Program, Ohio State University: Transcranial Direct Current Stimulation
• Additional relevant MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Sleepiness

Study Results

Participant Flow

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
Period Title: Overall Study
STARTED	30
COMPLETED	26
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.33 (7.08)
Sex: Female, Male (Count of Participants)
Female	24 92.3%
Male	2 7.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.8%
Not Hispanic or Latino	24 92.3%
Unknown or Not Reported	1 3.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 7.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 15.4%
White	18 69.2%
More than one race	2 7.7%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Psychomotor Vigilance Test
Description	Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.
Time Frame	3 minutes

Outcome Measure Data

Analysis Population Description

Objective sleepiness based on Psychomotor Vigilance Test could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
Measure Participants	0

2. Primary Outcome

Title	Karolinska Sleepiness Scale
Description	Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

Subjective sleepiness based on Karolinska Sleepiness Scale instrument could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
Measure Participants	0

3. Secondary Outcome

Title	Epworth Sleepiness Scale
Description	Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported.
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

Subjective sleepiness based on Epworth Sleepiness Scale instrument could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
Measure Participants	0

Adverse Events

Time Frame	Adverse events were assessed through study completion (6 weeks for each participant).
Adverse Event Reporting Description	No adverse events were observed or reported during the study.
Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. 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.
All Cause Mortality
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Serious Adverse Events
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/26 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.