- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02176785
The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29401
- Medical University of South Carolina
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep onset latency and sleep architecture
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep quality
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Power Nap
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Søvn
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University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
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Nutrition Institute, SloveniaValens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... og andre samarbejdspartnereRekrutteringSøvnkvalitet | Sleep Onset LatencySlovenien
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Mahidol UniversityRamathibodi HospitalIkke rekrutterer endnuSøvninerti | Søvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | NatskiftarbejdeThailand
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University of ArizonaNational Heart, Lung, and Blood Institute (NHLBI)Ikke rekrutterer endnu
-
Haseki Training and Research HospitalIkke rekrutterer endnuRichards-Campbell Sleep Questionnaire (RCSQ)
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National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
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Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... og andre samarbejdspartnereIkke rekrutterer endnuSøvnkvalitet | Sleep Onset LatencySlovenien
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Fu Jen Catholic University HospitalIkke rekrutterer endnuSedation | DISE | OSAS (Obstructive Sleep Apneas Syndrome)Taiwan
Kliniske forsøg med transcranial Direct Current Stimulation (tDCS)
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Minneapolis Veterans Affairs Medical CenterCenter for Veterans Research and EducationAfsluttetFedme | Impulsivitet | Kompulsiv overspisningForenede Stater
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NYU Langone HealthNational Institute for Biomedical Imaging and Bioengineering (NIBIB)RekrutteringDepressionForenede Stater
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