Trial Outcomes & Findings for Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD) (NCT NCT03879044)

Last Updated: 2021-10-25

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

3 minutes

Results posted on

2021-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We analyzed data of participants who fully complete baseline questionnaires

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Current Stimulation n=26 Participants 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.
Age, Continuous	31.33 years STANDARD_DEVIATION 7.08 • n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Sex: Female, Male Female	24 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Sex: Female, Male Male	2 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) Asian	2 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) White	18 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) More than one race	2 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires
Region of Enrollment United States	26 Participants n=5 Participants • We analyzed data of participants who fully complete baseline questionnaires

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Direct Current Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ulysses Magalang

The Ohio State University Wexner Medical Center

Phone: 614-292- 4307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place