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Infra-slow Oscillations During Sleep (SleepD-ISO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02532608
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : August 22, 2018
Information provided by (Responsible Party):
Stephany Fulda, Neurocenter of Southern Switzerland

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 26, 2015
Last Update Posted Date August 22, 2018
Study Start Date  ICMJE October 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
Infra-slow frequency power [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Infra-slow Oscillations During Sleep
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy Subjects
  • Restless Legs Syndrome
  • Periodic Limb Movements During Sleep
Intervention  ICMJE Other: Acute sleep deprivation
Participants will stay awake for 36 hours
Study Arms  ICMJE Experimental: Acute sleep deprivation
Registration of habitual sleep and sleep after sleep deprivation
Intervention: Other: Acute sleep deprivation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02532608
Other Study ID Numbers  ICMJE EOC.NSI.LS.15.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stephany Fulda, Neurocenter of Southern Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stephany Fulda
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephany Fulda, PhD Neurocenter of Southern Switzerland
PRS Account Neurocenter of Southern Switzerland
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP