Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children (NANOS)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 24, 2011 | ||||
| Last Updated Date | March 24, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children | ||||
| Official Title ICMJE | Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors | ||||
| Brief Summary | Principal aim: To determine the prevalence of Sleep Apnea- Hypopnea syndrome in obese children. Secondary aim: 1. To fix the implication of the adenotonsillar hypertrophy, the obesity and the hormonal factors in the pathogeny of SAHS in children. 2. To determinate of clinical and neurophysiologic characteristics of childhood SAHS associated with obesity. DESIGN: A prospective transversal study. |
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| Detailed Description | The population of study will be make for children of both sex, between 3 and 14 years old and with body mass index (BMI) ≥ 95 percentile and with informed consent. METHODS: In all children included in the study, the investigators will carry out: previous history, history of snoring and Chervin´s screening questionnaire of SAHS, general physical and otorhinolaryngologic examination with nasopharyngoscopy, blood test with determination of glucose, lipids, insulin, leptin, adiponectin, and ghrelin, polysomnography (PSG) with transcutaneous CO2. The diagnosis of SAHS will be made if on PSG the Respiratory disturbance Index (RDI) is ≥ 3 and/or obstructive hypoventilation is present. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The population of study will be make for children of both sex, between 3 and 14 years old and with body mass index (BMI) ≥ 95 percentile and with informed consent. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 14 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01322763 | ||||
| Other Study ID Numbers ICMJE | PI755 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Juan Ruiz Manzano, Spanish Society of Pneumology and Thoracic Surgery | ||||
| Study Sponsor ICMJE | Sociedad Española de Neumología y Cirugía Torácica | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sociedad Española de Neumología y Cirugía Torácica | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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