Brain Maturation and Sleep (BMS)

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Active, not recruiting

Conditions

Healthy

Treatments

Other: sham condition
Other: Playing tones during deep sleep

Study type

Interventional

Funder types

Other

Identifiers

NCT02685891
PB_2016-00254

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

8 to 30 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

90 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Carina Volk

Data sourced from clinicaltrials.gov

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