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

Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Sensory stimulation during sleep

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6903
      • Neurocenter of Southern Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arousal probability	Number stimuli that are followed by an EEG arousal divided by the total number of stimuli	8 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EOC.NSI.LS.18.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data and metadata generating in this project will be deposited onto existing public repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No