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The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT

31. juli 2018 opdateret af: Medical University of South Carolina
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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Medical University of South Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham tDCS
tDCS will be applied, but then turned off after 30 seconds.
tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andre navne:
  • Chattanooga Ionto™ Iontophoresis System - Phoresor.
Eksperimentel: Anodal tDCS 2mA 10 Minutes
Anodal tDCS will be applied bi-frontally for 10 minutes at 2mA
tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andre navne:
  • Chattanooga Ionto™ Iontophoresis System - Phoresor.
Eksperimentel: Cathodal tDCS 2mA 10 Minutes
Cathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA
tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Andre navne:
  • Chattanooga Ionto™ Iontophoresis System - Phoresor.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep onset latency and sleep architecture
Tidsramme: 30 Minutes
Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.
30 Minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep quality
Tidsramme: 30 Minutes
Sleep quality will be assessed with a visual analog scale following each nap opportunity.
30 Minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2014

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

24. juni 2014

Først indsendt, der opfyldte QC-kriterier

26. juni 2014

Først opslået (Skøn)

27. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Power Nap

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvn

Kliniske forsøg med transcranial Direct Current Stimulation (tDCS)

Abonner