Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children (NANOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01322763
First received: March 24, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 24, 2011
March 24, 2011
March 2008
May 2011   (final data collection date for primary outcome measure)
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No Changes Posted
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Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children. The Significance of Hormonal Factors

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.

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.

Observational
Time Perspective: Prospective
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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.

  • Sleep Apnea
  • Children
  • Obesity
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Alonso-Álvarez ML, Cordero-Guevara JA, Terán-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Peñafiel J, Duran-Cantolla J, Kheirandish-Gozal L, Gozal D. Obstructive sleep apnea in obese community-dwelling children: the NANOS study. Sleep. 2014 May 1;37(5):943-9. doi: 10.5665/sleep.3666.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2012
May 2011   (final data collection date for primary outcome measure)

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
Both
3 Years to 14 Years
No
Contact: María Luz Alonso Alvarez, MD 34610246473 mlalonso@hgy.es
Spain
 
NCT01322763
PI755
Not Provided
Juan Ruiz Manzano, Spanish Society of Pneumology and Thoracic Surgery
Sociedad Española de Neumología y Cirugía Torácica
Not Provided
Principal Investigator: Maria Luz Alonso-Álvarez, MD Sleep Unit. Complejo Asistencial Universitario Burgos. Spain
Sociedad Española de Neumología y Cirugía Torácica
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP