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Sleep Infra-slow Oscillations III (Sleep-ISO III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681327
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2018
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Stephany Fulda, Neurocenter of Southern Switzerland

Study Description
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Brief Summary:
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.

Condition or disease Intervention/treatment Phase
Healthy Other: Sensory stimulation during sleep Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Intervention Details:
  • Other: Sensory stimulation during sleep
    Sensory stimulation during sleep

Outcome Measures
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Primary Outcome Measures :
  1. Arousal probability [ Time Frame: 8 hours ]
    Number stimuli that are followed by an EEG arousal divided by the total number of stimuli


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willingness to participate and written informed consent
  • Aged 20 to 40 years at the time of screening
  • Body mass index (BMI) ≤ 30

Exclusion Criteria:

  • Pregnancy or breast feeding at the time of screening
  • Sleep related breathing disorders
  • Any other sleep related breathing disorder according to AASM criteria
  • Current history of psychiatric disorders according to DSM-V
  • Current chronic treatment that may affect sleep
  • Any significant neurological disorder or other medical disease that may affect sleep
  • Any unstable medical condition
  • Any clinically significant sleep disorder
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03681327


Locations
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Switzerland
Neurocenter of Southern Switzerland
Lugano, Ticino, Switzerland, 6903
Sponsors and Collaborators
Neurocenter of Southern Switzerland
Investigators
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Principal Investigator: Stephany Fulda, PhD Neurocenter of Southern Switzerland
More Information
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Responsible Party: Stephany Fulda, Stephany Fulda, Principal Investigator, Neurocenter of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03681327    
Other Study ID Numbers: EOC.NSI.LS.18.1
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data and metadata generating in this project will be deposited onto existing public repositories.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No