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
|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)|
|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|
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.
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
|Contact: Stephany Fulda, PhD||+41 91 811 ext email@example.com|
|Neurocenter of Southern Switzerland||Recruiting|
|Lugano, Ticino, Switzerland, 6903|
|Contact: Stephany Fulda, PhD +41 91811 ext 6962 firstname.lastname@example.org|
|Principal Investigator:||Stephany Fulda, PhD||Neurocenter of Southern Switzerland|