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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00841347 |
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Date of registration:
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10/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sleep and Obesity in Teenagers
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Scientific title:
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Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers. |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00841347 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Karine SPIEGEL, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Name:
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Behrouz KASSAI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female over 15 and under 18 year-old.
- Teenager with normal weight or stage 2 obesity, according to international standards
(WHO)
- Post-pubescent teenagers (menstruation for girls and stage 4-5 of Tanner scale for
boys)
- Teens with an social security
- Girl with negative urine pregnancy test
Exclusion Criteria:
- Active smoker (interview)
- Refuse consent (parents or teen)
- Addiction such as coffee, drug…(interview)
- Medicinal treatment that may influence sleep and measured variables (interview)
- Obesity diagnosis : less than 1 year (interview)
- Concomitant diseases : renal or hepatic failure, iron deficit, diabetes, endocrinal
pathology, hypertension
- Anxiety (Spielberg>56), , depression (CDI>19).
- Mild or sever insomnia (ISI>15), poor sleep quality (PSQI >10), excessive sleepiness
(Epworth>10, sleep) length>9 hour), extreme circadian typology (Horne et Ostberg from
70 to 86 or 16 to 30)
- Blood sample taken within the last two months before inclusion
- Mild or severe sleep apnoea or excessive leg movements according to EEG analysis
Age minimum:
15 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: habitual sleep length period + extended sleep length period
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Behavioral: extended sleep length period + habitual sleep length period
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Primary Outcome(s)
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The influence of sleep extension on leptin level for the obese teens group.
[Time Frame: at the end of each sleep experimental period]
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Secondary Outcome(s)
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Study the correlation between delta waves activity and habitual sleep length
[Time Frame: During each sleep experimental period]
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Study the correlation between delta waves activity and psychological, behavioural, anthropometric and physiological markers of obesity and its co morbidities
[Time Frame: During each sleep experimental period]
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Difference between the two groups (obese vs non-obese) regarding sleep length and delta waves activity.
[Time Frame: during each sleep experimental period (habitual or extended)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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