The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29401
- Medical University of South Carolina
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Sham-vergelijker: Sham tDCS
tDCS will be applied, but then turned off after 30 seconds.
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tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andere namen:
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Experimenteel: Anodal tDCS 2mA 10 Minutes
Anodal tDCS will be applied bi-frontally for 10 minutes at 2mA
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tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andere namen:
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Experimenteel: Cathodal tDCS 2mA 10 Minutes
Cathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA
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tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sleep onset latency and sleep architecture
Tijdsspanne: 30 Minutes
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Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.
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30 Minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sleep quality
Tijdsspanne: 30 Minutes
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Sleep quality will be assessed with a visual analog scale following each nap opportunity.
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30 Minutes
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Power Nap
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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