Infra-slow Oscillations During Sleep (SleepD-ISO)

• ClinicalTrials.gov Identifier: NCT02532608
• Recruitment Status: Completed
• First Posted: August 26, 2015
• Last Update Posted: August 22, 2018
• Sponsor: Stephany Fulda
• Information provided by (Responsible Party): Stephany Fulda, Neurocenter of Southern Switzerland

Tracking Information

• First Submitted Date: August 21, 2015
• First Posted Date: August 26, 2015
• Last Update Posted Date: August 22, 2018
• Study Start Date: October 2015
• Actual Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2015)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Infra-slow Oscillations During Sleep
• 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
• 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:

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

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

Intervention

Other: Acute sleep deprivation

Participants will stay awake for 36 hours

Study Arms

Experimental: Acute sleep deprivation

Registration of habitual sleep and sleep after sleep deprivation

Intervention: Other: Acute sleep deprivation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 20, 2018): 18
• Original Estimated Enrollment (submitted: August 25, 2015): 20
• Actual Study Completion Date: August 2017
• Actual Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02532608
• Other Study ID Numbers: EOC.NSI.LS.15.2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stephany Fulda, Neurocenter of Southern Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: Stephany Fulda
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Neurocenter of Southern Switzerland
• Verification Date: August 2018