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

Primary Purpose

Shift-Work Sleep Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shift-Work Sleep Disorder focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

Psychomotor Vigilance Test
Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.
Karolinska Sleepiness Scale
Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2019
Last Updated
October 22, 2021
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03879044
Brief Title
Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)
Acronym
tDCS-SWORD
Official Title
Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding stopped
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
Keywords
Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
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
Title
Karolinska Sleepiness Scale
Description
Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.
Time Frame
5 minutes
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulysses Magalang, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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