Brain Maturation and Sleep (BMS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Playing tones during deep sleep; Other: sham condition

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina Volk; Phone Number: +41 44 266 8186; Email: carina.volk@kispi.uzh.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: playing tones; During slow-wave sleep short tones (50ms, 50dB) will be played	Other: Playing tones during deep sleep; Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)
Sham Comparator: Playing no tones; During slow-wave sleep no tones will be played	Other: sham condition; in the sham condition, no tones will be played

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	structural markers (MR volumes) change in dependance of the diurnal variation of brain metabolites	3 years

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 15, 2016
• First Posted (Estimated): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PB_2016-00254

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No