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.
Investigators
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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