NCT03681327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

4.8 years

First QC Date

September 20, 2018

Last Update Submit

November 7, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Arousal probability

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

    8 hours

Interventions

Sensory stimulation during sleepOTHER

Sensory stimulation during sleep

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

Location

Study Officials

  • Stephany Fulda, PhD

    Neurocenter of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stephany Fulda, Principal Investigator

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

October 1, 2018

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The data and metadata generating in this project will be deposited onto existing public repositories.

Locations

CH(1)