Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

Obesity Clinical Trial

— NANOS  

Official title:

Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01322763
• Other study ID #: PI755
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 24, 2011
• Start date: March 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2011
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: María Luz Alonso Alvarez, MD
• Phone: 34610246473
• Email: mlalonso[@]hgy.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children of both sex, between 3 and 14 years old

• Body mass index (BMI) = 95 percentile

• With informed consent.

Exclusion Criteria:

• Without informed consent

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Children
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de Burgos	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain,