Brain Maturation and Sleep | NCT02685891

Studies
Brain Maturation and Sleep

NCT02685891

Sponsor

University Children's Hospital, Zurich

Status

Unknown status

Last Update Posted

Jan 30, 2024Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Playing tones during deep sleep
sham condition

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 4, 2016

First Submission Date that Met QC Criteria

Feb 15, 2016

First Posted Date

Feb 19, 2016Estimated

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

Jan 29, 2024

Last Update Posted Date

Jan 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 this study, the investigator evaluates whether there are age-specific diurnal changes in markers of cortical plasticity in children, adolescents and adults. The question will be investigated by the quantification of brain metabolites and structural brain volumes using magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity change depending on a modulation of sleep by applying tones during deep sleep.

Detailed Description

Given that children and adolescents undergo entirely different maturational processes (children show an increase, adolescents a decrease in synapse density) larger diurnal changes in children are expected compared to adolescents concerning brain metabolites and structural markers. These cortical changes in synapse density are thought to be reflected in electrophysiological markers in the sleep EEG (children show a higher slow wave activity, adolescents a reduced slow wave activity). With the modulation of the deep (slow wave) sleep by playing short, low volume tones, the investigators want to test if there is a causal relationship between slow wave sleep and markers of cortical plasticity.

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
playing tones	Active Comparator	During slow-wave sleep short tones (50ms, 50dB) will be played	Other: Playing tones during deep sleep
Playing no tones	Sham Comparator	During slow-wave sleep no tones will be played	Other: sham condition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Playing tones during deep sleep	Other	Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)	playing tones

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diurnal changes in brain metabolites	concentration of brain metabolites measured by MR spectroscopy change from evening to morning	3 years

Secondary Outcomes

Measure	Description	Time Frame
electrophysiological markers change in dependance of the diurnal variation of brain metabolites	electrophysiological markers (sleep EEG) change in dependance of the diurnal variation of brain metabolites	3 years
structural markers change in dependance of the diurnal variation of brain metabolites

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects 8 to 30 years of age,
good general health Status
right-handedness,
Written informed consent after participants' information

Exclusion Criteria:

sleep disorders (insomnia, sleep disordered breathing, restless legs syndrome)
sleep complaints in general
irregular sleep-wake rhythm
daytime sleep
travelling across a time zone within the last month
diseases or lesions of the central nervous system
psychiatric diseases
learning disability
skin allergy or very sensitive skin
acute pediatric disease
pregnancy
drug and medication use and abuse
nicotine use
high caffeine consumption (>2 servings/day (>160 mg caffeine); including coffee, tea, white and dark chocolate, coca cola, energy drink)
Alcohol consumption in children and adolescents under 16 years
high alcohol consumption in adults (> 1 standard serving/day (>14 mg Alcohol))
high alcohol consumption in adolescents aged 16 years and above (> 3-4 Standard servings per week)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided