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Infra-slow Oscillations During Sleep (SleepD-ISO)

20. august 2018 opdateret af: Stephany Fulda

Infra-slow Oscillations During Sleep, After Acute Sleep Deprivation and in Subjects With Restless Legs Syndrome/Periodic Leg Movements During Sleep (RLS/PLMS): an Explorative, Prospective, Monocentric, Observational Case-control and Interventional Study

In this study the investigators plan to systematically characterise infra-slow EEG oscillations during sleep, explore their relationship to the microstructure of sleep, and investigate its role in the physiology and pathophysiology of sleep by co-registration of Full band EEG with polysomnography during wake and sleep in healthy subjects, after sleep deprivation, and in patients with restless legs syndrome/periodic leg movements during sleep (RLS/PLMS).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sleep is a highly dynamic process and during large parts of sleep the level of arousal fluctuates on a multi-second time scale between the sleep stage specific background and transient, phasic events that clearly arise from this background and constitute the microstructure of sleep. This microstructure is part of the dynamic physiological sleep regulation and at the same time reflects the instability of sleep, is critically involved in the pathophysiology of sleep and a determinant of the recuperative value of sleep and daytime performance.

Intriguingly, these sleep microstructural fluctuations are in a multi-second range that corresponds closely to the so-called infra-slow oscillations that are ubiquitous in the central nervous system. Infra-slow oscillations (0.01 - 0.1 Hz) have been observed in both humans and animals across brain structures and spatial scales in the dynamics of single unit firing rates, direct electrical potential fluctuations and oscillation amplitude modulations. The possibility to record these infra-slow oscillations on the level of the surface EEG with direct current (DC) or Full band (Fb) EEG offers a new approach to study the microstructure of sleep and characterise the full range of sleep-related EEG oscillations.

The objectives of this study are:

  1. to record and systematically characterise infra-slow oscillations during wake and all stages of sleep
  2. to explore the relationship between sleep infra-slow oscillations and microstructural events of sleep, in particular the cyclic alternating pattern
  3. to explore the effect of acute sleep deprivation on sleep infra-slow EEG activity
  4. to investigate infra-slow sleep EEG activity in patients with RLS/PLMS, common sleep disorders with prominent periodic arousals, heart rate activations, and leg movements
  5. to explore the relationship between infra-slow EEG oscillations and periodic events in movement and autonomic system activity in patients with RLS/PLMS.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Schweiz
    • Ticino
      • Lugano, Ticino, Schweiz, 6903
        • Neurocenter of Southern Switzerland

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

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria for all participants:

  • Willingness to participate and written informed consent
  • Aged 20 to 40 years at the time of screening
  • Body mass index (BMI) ≤ 30

Additional inclusion criteria for subjects with RLS/PLMS:

  • Either diagnosis of RLS and current IRLS score ≥ 15.
  • Or frequent periodic leg movements during sleep

Exclusion criteria for all participants:

  • Pregnancy or breast feeding at the time of screening
  • Sleep related breathing disorders
  • Current psychiatric disorders
  • Current chronic treatment that may affect sleep.
  • Any significant neurological disorder or other medical disease that may affect sleep.
  • Any unstable medical condition.

Additional exclusion criteria for participants with RLS/PLMS:

  • Current intake of dopaminergic drugs
  • Current intake of other RLS relevant medication
  • Intake of hypnotics
  • Other significant sleep disorder except symptoms potentially related to RLS

Additional exclusion criteria for healthy participants:

  • Any pharmacological treatment that may affect sleep and/or sleep related movement disorders
  • Any clinically significant sleep disorders

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acute sleep deprivation
Registration of habitual sleep and sleep after sleep deprivation
Andet: Acute sleep deprivation
Participants will stay awake for 36 hours

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infra-slow frequency power
Tidsramme: 36 hours
Average power (µV) in the infra-slow frequency range during wake and different stages of sleep derived from standard fast fourier transform and continuous wavelet transform.
36 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Stephany Fulda

Efterforskere

  • Ledende efterforsker: Stephany Fulda, PhD, Neurocenter of Southern Switzerland

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. oktober 2015

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

21. august 2015

Først indsendt, der opfyldte QC-kriterier

25. august 2015

Først opslået (Skøn)

26. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EOC.NSI.LS.15.2

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 Restless Legs Syndrome

Kliniske forsøg med Acute sleep deprivation

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