Infra-slow Oscillations During Sleep (SleepD-ISO)
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|ClinicalTrials.gov Identifier: NCT02532608|
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : August 22, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects Restless Legs Syndrome Periodic Limb Movements During Sleep||Other: Acute sleep deprivation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 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|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: Acute sleep deprivation
Registration of habitual sleep and sleep after sleep deprivation
Other: Acute sleep deprivation
Participants will stay awake for 36 hours
- 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.
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|Ages Eligible for Study:||20 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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
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
|Neurocenter of Southern Switzerland|
|Lugano, Ticino, Switzerland, 6903|
|Principal Investigator:||Stephany Fulda, PhD||Neurocenter of Southern Switzerland|
|Responsible Party:||Stephany Fulda, PhD, Neurocenter of Southern Switzerland|
|Other Study ID Numbers:||
|First Posted:||August 26, 2015 Key Record Dates|
|Last Update Posted:||August 22, 2018|
|Last Verified:||August 2018|
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders