Sleep Infra-slow Oscillations III | NCT03681327

Studies
Sleep Infra-slow Oscillations III

NCT03681327

Sponsor

Neurocenter of Southern Switzerland

Status

Completed

Last Update Posted

Nov 8, 2023Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Sensory stimulation during sleep

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Sep 20, 2018

First Submission Date that Met QC Criteria

Sep 20, 2018

First Posted Date

Sep 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephany Fulda, Stephany Fulda, Principal Investigator, Neurocenter of Southern SwitzerlandPrincipal Investigator

Lead Sponsor

Neurocenter of Southern SwitzerlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sensory stimulation during sleep	Other	Sensory stimulation during sleep

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephany Fulda, PhD	Neurocenter of Southern Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurocenter of Southern Switzerland		Lugano	Canton Ticino	6903	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided