Infra-slow Oscillations During Sleep (SleepD-ISO)

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).

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome; Healthy Subjects; Periodic Limb Movements During Sleep
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infra-slow frequency power	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

Collaborators and Investigators

• Sponsor: Stephany Fulda
• Investigators: Principal Investigator: Stephany Fulda, PhD, Neurocenter of Southern Switzerland

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: EOC.NSI.LS.15.2