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OpenTrials
Completed

NCT Number: NCT03681327

Sleep Infra-slow Oscillations III

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

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory stimulation during sleep

Other

Sensory stimulation during sleep

Primary outcomes

  1. Arousal probability

    Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

Neurocenter of Southern Switzerland

Other

Registry information

Official study 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

Acronym: Sleep-ISO III

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2018
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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