Brain Maturation and Sleep

Healthy Clinical Trial

— BMS  

Official title:

Exploring Diurnal Changes in Markers of Cortical Plasticity Using Multimodal Imaging in Healthy Children, Adolescents and Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02685891
• Other study ID #: PB_2016-00254
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Playing tones during deep sleep
Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)
• sham condition
in the sham condition, no tones will be played

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal changes in brain metabolites	concentration of brain metabolites measured by MR spectroscopy change from evening to morning	3 years
Secondary	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
Secondary	structural markers change in dependance of the diurnal variation of brain metabolites	structural markers (MR volumes) change in dependance of the diurnal variation of brain metabolites	3 years