The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
1 other identifier
interventional
10
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 2, 2018
May 1, 2018
2 months
June 24, 2014
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep onset latency and sleep architecture
Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.
30 Minutes
Secondary Outcomes (1)
Sleep quality
30 Minutes
Study Arms (3)
Sham tDCS
SHAM COMPARATORtDCS will be applied, but then turned off after 30 seconds.
Anodal tDCS 2mA 10 Minutes
EXPERIMENTALAnodal tDCS will be applied bi-frontally for 10 minutes at 2mA
Cathodal tDCS 2mA 10 Minutes
EXPERIMENTALCathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA
Interventions
tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Sahlem, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 27, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 2, 2018
Record last verified: 2018-05