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Infra-slow Oscillations During Sleep (SleepD-ISO)

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ClinicalTrials.gov Identifier: NCT02532608
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Healthy Subjects Restless Legs Syndrome Periodic Limb Movements During Sleep Other: Acute sleep deprivation

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Acute sleep deprivation
Registration of habitual sleep and sleep after sleep deprivation
Other: Acute sleep deprivation
Participants will stay awake for 36 hours


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532608


Contacts
Contact: Stephany Fulda, PhD +41 91 811 ext 6962 stephany.fulda@gmail.com

Locations
Switzerland
Neurocenter of Southern Switzerland Recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Stephany Fulda, PhD    +41 91811 ext 6962    stephany.fulda@gmail.com   
Sponsors and Collaborators
Stephany Fulda
Investigators
Principal Investigator: Stephany Fulda, PhD Neurocenter of Southern Switzerland
More Information

Responsible Party: Stephany Fulda, PhD, Neurocenter of Southern Switzerland
ClinicalTrials.gov Identifier: NCT02532608     History of Changes
Other Study ID Numbers: EOC.NSI.LS.15.2
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders