Infra-slow Oscillations During Sleep

NCT02532608 | Completed

• 1 other identifier: EOC.NSI.LS.15.2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Acute sleep deprivation

EXPERIMENTAL

Registration of habitual sleep and sleep after sleep deprivation

Other: Acute sleep deprivation

Interventions

Acute sleep deprivation OTHER

Participants will stay awake for 36 hours

Acute sleep deprivation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willingness to participate and written informed consent
• Aged 20 to 40 years at the time of screening
• Body mass index (BMI) ≤ 30
• Either diagnosis of RLS and current IRLS score ≥ 15.
• Or frequent periodic leg movements during sleep

You may not qualify if:

• 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.
• 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
• Any pharmacological treatment that may affect sleep and/or sleep related movement disorders
• Any clinically significant sleep disorders

Sponsors & Collaborators

• Stephany Fulda: lead

Study Sites (1)

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Stephany Fulda, PhD

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 26, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

CH (1)