NCT01322763

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 25, 2011

Status Verified

March 1, 2011

Enrollment Period

3.2 years

First QC Date

March 24, 2011

Last Update Submit

March 24, 2011

Conditions

Sleep ApneaChildrenObesity

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Children of both sex, between 3 and 14 years old
  • Body mass index (BMI) ≥ 95 percentile
  • With informed consent.

You may not qualify if:

  • Without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Asistencial Universitario de Burgos

Burgos, Burgos, 09005, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28899517DERIVED

  • 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.

    PMID: 26065566DERIVED

  • 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.

    PMID: 25801692DERIVED

  • 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.

    PMID: 24991089DERIVED

  • 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.

    PMID: 24790273DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesObesity

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Luz Alonso-Álvarez, MD

    Sleep Unit. Complejo Asistencial Universitario Burgos. Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Luz Alonso Alvarez, MD

CONTACT

34610246473mlalonso@hgy.es

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2008

Primary Completion

May 1, 2011

Study Completion

January 1, 2012

Last Updated

March 25, 2011

Record last verified: 2011-03

Locations

ES(1)