CClinicalTrials.gg
Active, not recruitingNCT02685891BMSUpdated Jan 30, 2024

Brain Maturation and Sleep

An interventional study of Playing tones during deep sleep and sham condition in Healthy, sponsored by University Children's Hospital, Zurich. Active, not recruiting at 1 site in Switzerland. Open to participants aged 8 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
8 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    playing tones

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

    Other: Playing tones during deep sleep

  • Sham comparator
    Playing no tones

    During slow-wave sleep no tones will be played

    Other: sham condition

Interventions

  • OtherPlaying tones during deep sleep

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

  • Othersham condition

    in the sham condition, no tones will be played

06

What researchers measure

Primary outcomes

  1. Diurnal changes in brain metabolites

    concentration of brain metabolites measured by MR spectroscopy change from evening to morning

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 3 years

  2. 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

    Time frame: 3 years

07

Study locations

1 site
  • University Children's Hospital Zurich
    Zurich, 8032, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02685891
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Sponsor
First posted
Feb 19, 2016
Start date
Jun 2016
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 30, 2024

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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