Clinical Trials Directory

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.