Brain Maturation and Sleep

NCT ID: NCT02685891

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2025-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

playing tones

During slow-wave sleep short tones (50ms, 50dB) will be played

Group Type: ACTIVE_COMPARATOR

Playing tones during deep sleep

Intervention Type: OTHER

Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)

Playing no tones

During slow-wave sleep no tones will be played

Group Type: SHAM_COMPARATOR

sham condition

Intervention Type: OTHER

in the sham condition, no tones will be played

Interventions

Playing tones during deep sleep

Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)

Intervention Type: OTHER

sham condition

in the sham condition, no tones will be played

Intervention Type: OTHER

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Children's Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

PB_2016-00254

Identifier Type: -

Identifier Source: org_study_id