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Funding stopped
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported. | 5 minutes |
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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:
Stable medication dosage over previous 4 weeks.
Able to understand English and give a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulysses Magalang, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We analyzed data of participants who fully complete baseline questionnaires |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psychomotor Vigilance Test | Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported. | 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. | Posted | 3 minutes |
|
Adverse events were assessed through study completion (6 weeks for each participant).
No adverse events were observed or reported during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Outcome measurements and adverse events were not analyzed and reported as the study was terminated due to funding stopped
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ulysses Magalang | The Ohio State University Wexner Medical Center | 614-292- 4307 | Ulysses.Magalang@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2018 | Jul 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2018 | Jul 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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.
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|
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We analyzed data of participants who fully complete baseline questionnaires | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | We analyzed data of participants who fully complete baseline questionnaires | Count of Participants | Participants |
|
| Race (NIH/OMB) | We analyzed data of participants who fully complete baseline questionnaires | Count of Participants | Participants |
|
| Region of Enrollment | We analyzed data of participants who fully complete baseline questionnaires | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Karolinska Sleepiness Scale | Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported. | 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. | Posted | 5 minutes |
|
|
| Secondary | Epworth Sleepiness Scale | Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported. | 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. | Posted | 5 minutes |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |