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Infra-slow Oscillations During Sleep (SleepD-ISO)

Primary Purpose

Healthy Subjects, Restless Legs Syndrome, Periodic Limb Movements During Sleep

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Acute sleep deprivation
Sponsored by
Stephany Fulda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Subjects

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neurocenter of Southern Switzerland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute sleep deprivation

Arm Description

Registration of habitual sleep and sleep after sleep deprivation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2015
Last Updated
August 20, 2018
Sponsor
Stephany Fulda
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1. Study Identification

Unique Protocol Identification Number
NCT02532608
Brief Title
Infra-slow Oscillations During Sleep
Acronym
SleepD-ISO
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephany Fulda

4. Oversight

Data Monitoring Committee
No

5. 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).
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: to record and systematically characterise infra-slow oscillations during wake and all stages of sleep to explore the relationship between sleep infra-slow oscillations and microstructural events of sleep, in particular the cyclic alternating pattern to explore the effect of acute sleep deprivation on sleep infra-slow EEG activity 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 to explore the relationship between infra-slow EEG oscillations and periodic events in movement and autonomic system activity in patients with RLS/PLMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Restless Legs Syndrome, Periodic Limb Movements During Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute sleep deprivation
Arm Type
Experimental
Arm Description
Registration of habitual sleep and sleep after sleep deprivation
Intervention Type
Other
Intervention Name(s)
Acute sleep deprivation
Intervention Description
Participants will stay awake for 36 hours
Primary Outcome Measure Information:
Title
Infra-slow frequency power
Description
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.
Time Frame
36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephany Fulda, PhD
Organizational Affiliation
Neurocenter of Southern Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6903
Country
Switzerland

12. IPD Sharing Statement

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Infra-slow Oscillations During Sleep

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