Shift-Work Sleep Disorder
Conditions
Keywords
Transcranial Direct Current Stimulation
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.
Interventions
DEVICETranscranial 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.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Vigilance Test | 3 minutes | Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported. |
| Karolinska Sleepiness Scale | 5 minutes | Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | 5 minutes | Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation |
|---|---|
| Age, Continuous | 31.33 years STANDARD_DEVIATION 7.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Karolinska Sleepiness Scale
Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.
Time frame: 5 minutes
Population: 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.
Primary
Psychomotor Vigilance Test
Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.
Time frame: 3 minutes
Population: 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.
Secondary
Epworth Sleepiness Scale
Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported.
Time frame: 5 minutes
Population: 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.