Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children (NANOS)
Recruitment status was Recruiting
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors|
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322763
|Contact: María Luz Alonso Alvarez, MDfirstname.lastname@example.org|
|Complejo Asistencial Universitario de Burgos||Recruiting|
|Burgos, Spain, 09005|
|Contact: María Luz Alonso-Alvarez, MD 34610246473 email@example.com|
|Principal Investigator: Maria Luz Alonso-Alvarez, MD|
|Principal Investigator:||Maria Luz Alonso-Álvarez, MD||Sleep Unit. Complejo Asistencial Universitario Burgos. Spain|