Brain Maturation and Sleep

Not Applicable

Active, not recruiting

• Conditions: Healthy
• Interventions: Other: Playing tones during deep sleep; Other: sham condition

• Registration Number: NCT02685891
• Lead Sponsor: University Children's Hospital, Zurich

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.

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-19
• Study Start: 2016-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
playing tones	Playing tones during deep sleep	During slow-wave sleep short tones (50ms, 50dB) will be played
Playing no tones	sham condition	During slow-wave sleep no tones will be played

Primary Outcome Measures

Name	Time	Method
Diurnal changes in brain metabolites	3 years	concentration of brain metabolites measured by MR spectroscopy change from evening to morning

Secondary Outcome Measures

Name	Time	Method
electrophysiological markers change in dependance of the diurnal variation of brain metabolites	3 years	electrophysiological markers (sleep EEG) change in dependance of the diurnal variation of brain metabolites
structural markers change in dependance of the diurnal variation of brain metabolites	3 years	structural markers (MR volumes) change in dependance of the diurnal variation of brain metabolites

Trial Locations

Locations (1)

University Children's Hospital Zurich; 🇨🇭 Zurich, Switzerland