Trials / Unknown
UnknownNCT01322763
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
- Sex
- All
- Age
- 3 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2011-05-01
- Completion
- 2012-01-01
- First posted
- 2011-03-25
- Last updated
- 2011-03-25
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01322763. Inclusion in this directory is not an endorsement.