Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children (NANOS)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Sleep Apnea Children Obesity |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors |
| Estimated Enrollment: | 200 |
| 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.
Eligibility| Ages Eligible for Study: | 3 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations| Contact: María Luz Alonso Alvarez, MD | 34610246473 | mlalonso@hgy.es |
| Spain | |
| Complejo Asistencial Universitario de Burgos | Recruiting |
| Burgos, Spain, 09005 | |
| Contact: María Luz Alonso-Alvarez, MD 34610246473 mlalonso@hgy.es | |
| Principal Investigator: Maria Luz Alonso-Alvarez, MD | |
| Principal Investigator: | Maria Luz Alonso-Álvarez, MD | Sleep Unit. Complejo Asistencial Universitario Burgos. Spain |
More Information
No publications provided
| Responsible Party: | Juan Ruiz Manzano, Spanish Society of Pneumology and Thoracic Surgery |
| ClinicalTrials.gov Identifier: | NCT01322763 History of Changes |
| Other Study ID Numbers: | PI755 |
| Study First Received: | March 24, 2011 |
| Last Updated: | March 24, 2011 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Additional relevant MeSH terms:
|
Apnea Obesity Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Overnutrition Nutrition Disorders Overweight Body Weight Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013