Shift-Work Sleep DisordertDCS-SWORDNCT03879044
Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)
A study testing Transcranial Direct Current Stimulation in people with Shift-Work Sleep Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test
Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.
Measured: 3 minutes
Karolinska Sleepiness Scale
Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.
Measured: 5 minutes
Secondary outcomes (1)
Epworth Sleepiness Scale
Subjective measure of sleepiness. The scale ranges from 0-24, with the total score being reported.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 Mar 2019
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Why it stopped: Funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulysses Magalang MD, Ohio State University
- Investigators
- Ulysses Magalang, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879044
- Sponsor's protocol ID
- 2018H0139
- Acronym
- tDCS-SWORD
- Status last verified
- Oct 2021
- First submitted
- 12 Mar 2019
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)
- ClinicalTrials.gov ID
- NCT03879044
- Acronym / sponsor ID
- tDCS-SWORD / 2018H0139
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding stopped
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: Transcranial Direct Current StimulationActive tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCStDCS 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. | Device | Transcranial Direct Current Stimulation |
Primary outcome
Psychomotor Vigilance Test
Time frame: 3 minutes
Objective measure of sleepiness. Scale ranges between each individual, with the reciprocal of the reaction time being reported.
Karolinska Sleepiness Scale
Time frame: 5 minutes
Subjective measure of sleepiness. Scale ranges from 1-9, with total score being reported.
1 secondary outcome
Epworth Sleepiness Scale
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulysses Magalang, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Shift-Work Sleep Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Vigilance Test (time frame: 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.