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Clinical Trials/NCT03681327
NCT03681327
Completed
Not Applicable

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

Neurocenter of Southern Switzerland1 site in 1 country17 target enrollmentOctober 1, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Neurocenter of Southern Switzerland
Enrollment
17
Locations
1
Primary Endpoint
Arousal probability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Neurocenter of Southern Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Stephany Fulda

Stephany Fulda, Principal Investigator

Neurocenter of Southern Switzerland

Eligibility 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

Outcomes

Primary Outcomes

Arousal probability

Time Frame: 8 hours

Number stimuli that are followed by an EEG arousal divided by the total number of stimuli

Study Sites (1)

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