HealthyBMSNCT02685891
Brain Maturation and Sleep
A study testing Playing tones during deep sleep in people with Healthy, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Playing tones during deep sleep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and female subjects 8 to 30 years of age,
- good general health Status
- right-handedness,
- Written informed consent after participants' information
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Diurnal Changes in Markers of Cortical Plasticity Using Multimodal Imaging in Healthy Children, Adolescents and Adults
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.
- Conditions
- Healthy
- Being tested
- Playing tones during deep sleep, sham condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing tones during deep sleepOther
Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)
sham conditionOther
in the sham condition, no tones will be played
| Study group | Role | What they receive |
|---|---|---|
| playing tones | Active comparator | During slow-wave sleep short tones (50ms, 50dB) will be played Receives: Other: Playing tones during deep sleep |
| Playing no tones | Sham comparator | During slow-wave sleep no tones will be played Receives: Other: sham condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal changes in brain metabolites
concentration of brain metabolites measured by MR spectroscopy change from evening to morning
Measured: 3 years
Secondary outcomes (2)
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
Measured: 3 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685891
- Sponsor's protocol ID
- PB_2016-00254
- Acronym
- BMS
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2016
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Diurnal Changes in Markers of Cortical Plasticity Using Multimodal Imaging in Healthy Children, Adolescents and Adults
- ClinicalTrials.gov ID
- NCT02685891
- Acronym / sponsor ID
- BMS / PB_2016-00254
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| playing tones | Active comparator | Other: Playing tones during deep sleepDuring slow-wave sleep short tones (50ms, 50dB) will be played |
| Playing no tones | Sham comparator | Other: sham conditionDuring slow-wave sleep no tones will be played |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female subjects 8 to 30 years of age,
- good general health Status
- right-handedness,
- Written informed consent after participants' information
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playing tones during deep sleepPlaying tones time locked to slow waves (Duration:50ms, volume: 50dB) | Other | playing tones |
| sham conditionin the sham condition, no tones will be played | Other | Playing no tones |
Primary outcome
Diurnal changes in brain metabolites
Time frame: 3 years
concentration of brain metabolites measured by MR spectroscopy change from evening to morning
2 secondary outcomes
electrophysiological markers change in dependance of the diurnal variation of brain metabolites
Time frame: 3 years
structural markers change in dependance of the diurnal variation of brain metabolites
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playing tones during deep sleep in people with Healthy, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal changes in brain metabolites (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.