Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

NCT ID: NCT01322763

Last Updated: 2011-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea Children Obesity

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role lead

Responsible Party

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Spanish Society of Pneumology and Thoracic Surgery

Principal Investigators

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Maria Luz Alonso-Álvarez, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep Unit. Complejo Asistencial Universitario Burgos. Spain

Locations

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Complejo Asistencial Universitario de Burgos

Burgos, Burgos, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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María Luz Alonso Alvarez, MD

Role: CONTACT

34610246473

Facility Contacts

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María Luz Alonso-Alvarez, MD

Role: primary

34610246473

References

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Alonso-Alvarez ML, Teran-Santos J, Gonzalez Martinez M, Cordero-Guevara JA, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Ordax Carbajo E, MasaJimenez F, Kheirandish-Gozal L, Gozal D; Spanish Sleep Network. Metabolic biomarkers in community obese children: effect of obstructive sleep apnea and its treatment. Sleep Med. 2017 Sep;37:1-9. doi: 10.1016/j.sleep.2017.06.002. Epub 2017 Jun 22.

Reference Type DERIVED
PMID: 28899517 (View on PubMed)

Alonso-Alvarez ML, Teran-Santos J, Navazo-Eguia AI, Martinez MG, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Cordero-Guevara JA, Kheirandish-Gozal L, Gozal D; Spanish Sleep Network. Treatment outcomes of obstructive sleep apnoea in obese community-dwelling children: the NANOS study. Eur Respir J. 2015 Sep;46(3):717-27. doi: 10.1183/09031936.00013815. Epub 2015 Jun 11.

Reference Type DERIVED
PMID: 26065566 (View on PubMed)

Kheirandish-Gozal L, Gileles-Hillel A, Alonso-Alvarez ML, Peris E, Bhattacharjee R, Teran-Santos J, Duran-Cantolla J, Gozal D. Effects of adenotonsillectomy on plasma inflammatory biomarkers in obese children with obstructive sleep apnea: A community-based study. Int J Obes (Lond). 2015 Jul;39(7):1094-100. doi: 10.1038/ijo.2015.37. Epub 2015 Mar 24.

Reference Type DERIVED
PMID: 25801692 (View on PubMed)

Gileles-Hillel A, Alonso-Alvarez ML, Kheirandish-Gozal L, Peris E, Cordero-Guevara JA, Teran-Santos J, Martinez MG, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Gozal D. Inflammatory markers and obstructive sleep apnea in obese children: the NANOS study. Mediators Inflamm. 2014;2014:605280. doi: 10.1155/2014/605280. Epub 2014 Jun 1.

Reference Type DERIVED
PMID: 24991089 (View on PubMed)

Alonso-Alvarez ML, Cordero-Guevara JA, Teran-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Penafiel 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.

Reference Type DERIVED
PMID: 24790273 (View on PubMed)

Other Identifiers

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PI755

Identifier Type: -

Identifier Source: org_study_id

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