Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Chil... | NCT01322763

Studies
Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

NCT01322763

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Status

Unknown status

Last Update Posted

Mar 25, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Sleep Apnea
Children
Obesity

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

May 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Mar 24, 2011

First Submission Date that Met QC Criteria

Mar 24, 2011

First Posted Date

Mar 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2011

Last Update Posted Date

Mar 25, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sociedad Española de Neumología y Cirugía TorácicaOTHER

Collaborators

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

14 Years

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
María Luz Alonso Alvarez, MD	Contact	34610246473		mlalonso@hgy.es

Overall Officials

Name	Affiliation	Role
Maria Luz Alonso-Álvarez, MD	Sleep Unit. Complejo Asistencial Universitario Burgos. Spain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complejo Asistencial Universitario de Burgos	Recruiting	Burgos	Burgos	09005	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28899517	Derived	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.
26065566

ID	Term
D012891	Sleep Apnea Syndromes
D009765	Obesity

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic