NCT02532608

Completed

Infra-slow Oscillations During Sleep

Stephany Fulda Source

Other study identifiers

Sponsor study identifier

EOC.NSI.LS.15.2

Study Type

interventional

Actual enrollment (reported)

18

Locations

1 country

Sites

1

Timeline

Study Start

October 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2017

Actual (reported)

Study Completion

August 2017

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 18 participants
Study completion date: August 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 21, 2015
Actual (reported)
First Posted
August 26, 2015
Actual (reported)
Study Start
October 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)
Study Completion
August 2017
Actual (reported)

Last Updated: August 22, 2018
Status Verified: August 2018
Last Update Submitted: August 20, 2018

Conditions

Healthy Subjects Periodic Limb Movements During Sleep Restless Legs Syndrome

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 deprivationOther

Participants will stay awake for 36 hours

Acute sleep deprivation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Willingness to participate and written informed consent
Aged 20 to 40 years at the time of screening

Sponsors & Collaborators

Stephany Fulda
Otherlead

Study Sites (1)

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

Stephany Fulda, PhD
Neurocenter of Southern Switzerland
PRINCIPAL INVESTIGATOR

Enrollment

18 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableRecruiting

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

Contact the study team to confirm eligibility.

Primary Completion

August 2017

Actual (reported)

Study Completion

August 2017

Actual (reported)

Last Updated

August 22, 2018

Record last verified: 2018-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02532608
Data provider: ClinicalTrials.gov
Source updated: 2018-08-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:45 UTC

Locations

CH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Acute sleep deprivation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations