SleepNCT02176785
The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
A study testing transcranial Direct Current Stimulation (tDCS) in people with Sleep, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation technology that has demonstrated the ability to temporarily increase or decrease activity in specific regions of the brain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65
- capable of coming in for an initial intake screen, and then again for 2 hours on consecutive Monday, Wednesday, and Friday afternoons
Who cannot join
- Presence of Neurologic, psychiatric, or sleep disorder.
- Current use of medications affecting the central nervous system.
- Daily consumption of alcohol, or consequences of alcohol use (DUI, occupational, or social dysfunction ect.).
- Tobacco use.
- Consumption of more than the equivalent of 300mg of caffeine daily.
- Habitual sleep duration of less than 6 ½ hours, greater than 8 ½ hours, a difference between weeknight, and weekend sleep of greater than 3 hours, or typical sleep timing more than 3 hours outside of the window of 10pm-6am.
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- Score of greater than 5 on the Pittsburgh Sleep Quality Index (PSQ-I), or 10 on the Epworth Sleepiness scale (ESS).
- BMI greater than 30, or Heavy snoring.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
About this study
Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation technology that has demonstrated the ability to temporarily increase or decrease activity in specific regions of the brain. The researchers are investigating the effect of this technology on sleep propensity by applying two different types of stimulation as well as sham (Placebo) stimulation during three different afternoon naps. The researchers are subsequently hoping to recruit healthy volunteers without medical, or sleep problems who have a regular sleep schedule to participate in the study
Read the detailed description
Recent studies have demonstrated that there are cortical direct current (DC) changes that accompany sleep onset and transitions between sleep states in a stereotyped manner. In these studies it was determined that negative potential shifts occurred prior to and at the transition from wakefulness to sleep and at transitions between Rapid Eye Movement sleep (REM) sleep, and Non-Rapid Eye Movement (NREM) sleep. In a subset of experiments it was demonstrated that the same DC potential shifts occur during the transition from wake to sleep in an afternoon nap. The recorded DC potential shifts occurred predominantly in the pre-frontal cortex (F3, F4), with spread into central areas. No current literature exists that explores whether tDCS could be used to modulate cortical activity prior to sleep, resulting in either increased or decreased sleep propensity.
The application of focal, non-invasive brain stimulation has already led to novel and effective treatments for neuropsychiatric disease with minimal side effects (Most well studied in depression and repetitive Transcranial Magnetic Stimulation or, rTMS). Should the application of tDCS modulate sleep propensity it would represent a novel study paradigm with the potential to lead to a completely novel treatment for sleep disturbance. With this small pilot study, we propose taking the first step in exploring the utility of tDCS in modulating sleep propensity. We propose to recruit 15 healthy non-treatment seeking participants from the community and expose them to three total nap conditions in a randomized counter balanced fashion, with 10 minutes of either, Anodal, Cathodal, or Sham tDCS stimulation occurring prior to each nap opportunity.
- Conditions
- Sleep
- Being tested
- transcranial Direct Current Stimulation (tDCS)
- Keywords
- Sleep, Transcranial Electric Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Device
Also called Chattanooga Ionto™ Iontophoresis System - Phoresor.
tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | tDCS will be applied, but then turned off after 30 seconds. Receives: Device: transcranial Direct Current Stimulation (tDCS) |
| Anodal tDCS 2mA 10 Minutes | Experimental | Anodal tDCS will be applied bi-frontally for 10 minutes at 2mA Receives: Device: transcranial Direct Current Stimulation (tDCS) |
| Cathodal tDCS 2mA 10 Minutes | Experimental | Cathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA Receives: Device: transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset latency and sleep architecture
Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.
Measured: 30 Minutes
Secondary outcomes (1)
Sleep quality
Sleep quality will be assessed with a visual analog scale following each nap opportunity.
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176785
- Sponsor's protocol ID
- Power Nap
- Status last verified
- May 2018
- First submitted
- 24 Jun 2014
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
- ClinicalTrials.gov ID
- NCT02176785
- Acronym / sponsor ID
- Power Nap
- Conditions
- Sleep
- Keywords
- Sleep, Transcranial Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation technology that has demonstrated the ability to temporarily increase or decrease activity in specific regions of the brain. The researchers are investigating the effect of this technology on sleep propensity by applying two different types of stimulation as well as sham (Placebo) stimulation during three different afternoon naps. The researchers are subsequently hoping to recruit healthy volunteers without medical, or sleep problems who have a regular sleep schedule to participate in the study
Detailed description
Recent studies have demonstrated that there are cortical direct current (DC) changes that accompany sleep onset and transitions between sleep states in a stereotyped manner. In these studies it was determined that negative potential shifts occurred prior to and at the transition from wakefulness to sleep and at transitions between Rapid Eye Movement sleep (REM) sleep, and Non-Rapid Eye Movement (NREM) sleep. In a subset of experiments it was demonstrated that the same DC potential shifts occur during the transition from wake to sleep in an afternoon nap. The recorded DC potential shifts occurred predominantly in the pre-frontal cortex (F3, F4), with spread into central areas. No current literature exists that explores whether tDCS could be used to modulate cortical activity prior to sleep, resulting in either increased or decreased sleep propensity.
The application of focal, non-invasive brain stimulation has already led to novel and effective treatments for neuropsychiatric disease with minimal side effects (Most well studied in depression and repetitive Transcranial Magnetic Stimulation or, rTMS). Should the application of tDCS modulate sleep propensity it would represent a novel study paradigm with the potential to lead to a completely novel treatment for sleep disturbance. With this small pilot study, we propose taking the first step in exploring the utility of tDCS in modulating sleep propensity. We propose to recruit 15 healthy non-treatment seeking participants from the community and expose them to three total nap conditions in a randomized counter balanced fashion, with 10 minutes of either, Anodal, Cathodal, or Sham tDCS stimulation occurring prior to each nap opportunity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS)tDCS will be applied, but then turned off after 30 seconds. |
| Anodal tDCS 2mA 10 Minutes | Experimental | Device: transcranial Direct Current Stimulation (tDCS)Anodal tDCS will be applied bi-frontally for 10 minutes at 2mA |
| Cathodal tDCS 2mA 10 Minutes | Experimental | Device: transcranial Direct Current Stimulation (tDCS)Cathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65
- capable of coming in for an initial intake screen, and then again for 2 hours on consecutive Monday, Wednesday, and Friday afternoons
Key exclusion criteria (9 listed)
- Presence of Neurologic, psychiatric, or sleep disorder.
- Current use of medications affecting the central nervous system.
- Daily consumption of alcohol, or consequences of alcohol use (DUI, occupational, or social dysfunction ect.).
- Tobacco use.
- Consumption of more than the equivalent of 300mg of caffeine daily.
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 Stimulation (tDCS)Also: Chattanooga Ionto™ Iontophoresis System - Phoresor.tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor. | Device | Anodal tDCS 2mA 10 Minutes, Cathodal tDCS 2mA 10 Minutes, Sham tDCS |
Primary outcome
Sleep onset latency and sleep architecture
Time frame: 30 Minutes
Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.
1 secondary outcome
Sleep quality
Time frame: 30 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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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.
Gregory Sahlem, MD principal investigator
Medical University of South Carolina
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 (tDCS) in people with Sleep, run by Medical University of South Carolina 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 2 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep onset latency and sleep architecture (time frame: 30 Minutes). 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 2 Aug 2018.