- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02606591
Houston Independent School District (HISD) Yoga Evaluation
Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
If participant agrees to take part in this study, they will complete an electroencephalograph (EEG -- a test that measures the electrical activity of the brain), cognitive tests, and provide a hair sample shortly after they enter the study and again near the end of the school year.
The testing will take place in a room at participant's school chosen by the teachers. A member of the study staff will walk participant from their classroom and be with them the whole time the testing is taking place and then take them back to their classroom. If the testing is done before or after school, participant will stay with the member of study staff until their parent or guardian comes to pick them up.
During the EEG, researchers will place 19 electrodes on participant's head and 1 or 2 electrodes on each earlobe. Gel will be used to help attach the electrodes. The electrodes will measure and record participant's brain wave activity, similar to the way a doctor listens to their heart beat from the surface of their skin. During the EEG, participant will be also asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information. The EEG will take up to 5 minutes to set up and then 25 minutes for testing.
Participant will also provide a sample of hair, about 75 strands which is like the thickness of a pencil. The hair will tested to measure a stress hormone called cortisol. The hair will be destroyed after study testing.
Data obtained from the hair samples and EEG will be analyzed alongside the data participant is providing our collaborators at the University of San Diego and the Houston Independent School District.
The EEG that is collected for this study is for research purposes only. It is not the same as a "clinical EEG" that is used in medical diagnosis. The EEG that the study staff will collect looks at how the brain functions. It is not designed to look for medical conditions, the way that an MRI or CAT scan would be used. However, if a possible medical condition is suspected, participant will be told to follow up with their medical provider.
Length of Participation:
Participation on this study will be over after participant provides a hair sample, complete the EEG, and complete the cognitive tests the second time near the end of the school year.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part through MD Anderson at their schools.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Texas
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Houston, Texas, Stati Uniti, 77030
- University of Texas MD Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Fourth and Fifth graders in Houston Independent School District (HISD) schools that are participating in the Sonima Foundation's Health and Wellness Program
- Participant on USD study protocol.
Exclusion Criteria: 1)
- Participants who are taking any antipsychotic medications
- Participants with active central nervous system (CNS) disease or encephalopathy
- Participants who have ever been diagnosed with bipolar disorder or schizophrenia
- Participants who have a history of head injury or who have a known seizure activity.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Electroencephalograph (EEG) + Testing
Participants complete an electroencephalograph (EEG) cognitive tests, and provide a hair sample shortly after entering the study and again near the end of the school year.
Hair sample tested to measure a stress hormone called cortisol.
|
EEG performed at beginning and end of school year.
Altri nomi:
During the EEG, participant asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information.
Participants provide a sample of hair at baseline (near the beginning of school), and follow-up (near the end of school).
Sample tested to measure cortisol levels.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
Lasso di tempo: 9 months
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Trial feasible if 50% of students who are enrolled complete the EEG's.
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9 months
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Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program
Lasso di tempo: 9 months
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Trial feasible if 50% of students who are enrolled submit hair samples.
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9 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)
Lasso di tempo: At baseline and at 9 months
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Changes in EEG during each state (eyes open, eyes closed, and during cognitive testing) assessed using LORETA EEG analysis of brain function at baseline and the follow-up time point acquired through a Mitstar amplifier using WinEEG software.
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At baseline and at 9 months
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- PA15-0677
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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