Brain Maturation and Sleep

NCT02685891 | Unknown DMC

• 1 other identifier: PB_2016-00254
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Diurnal changes in brain metabolites

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

  3 years

Secondary Outcomes (2)

• electrophysiological markers change in dependance of the diurnal variation of brain metabolites

  3 years

• structural markers change in dependance of the diurnal variation of brain metabolites

  3 years

Study Arms (2)

playing tones

ACTIVE COMPARATOR

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

Other: Playing tones during deep sleep

Playing no tones

SHAM COMPARATOR

During slow-wave sleep no tones will be played

Other: sham condition

Interventions

Playing tones during deep sleep OTHER

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

playing tones

sham condition OTHER

in the sham condition, no tones will be played

Playing no tones

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects 8 to 30 years of age,
• good general health Status
• right-handedness,
• Written informed consent after participants' information

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 19, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CH (1)