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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322763
First Posted: March 25, 2011
Last Update Posted: March 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
  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

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

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)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322763


Contacts
Contact: María Luz Alonso Alvarez, MD 34610246473 mlalonso@hgy.es

Locations
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         
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Maria Luz Alonso-Álvarez, MD Sleep Unit. Complejo Asistencial Universitario Burgos. Spain
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan Ruiz Manzano, Spanish Society of Pneumology and Thoracic Surgery
ClinicalTrials.gov Identifier: NCT01322763     History of Changes
Other Study ID Numbers: PI755
First Submitted: March 24, 2011
First Posted: March 25, 2011
Last Update Posted: March 25, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases