NCT03950466

Brief Summary

OBJECTIVES: PRIMARY: To analyze the cognitive alterations in children with Obstructive Sleep Apnea OSA in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice. DESIGN: Observational, longitudinal, prospective, and multicenter 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
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

3.1 years

First QC Date

February 18, 2018

Last Update Submit

May 13, 2019

Conditions

Sleep Apnea, ObstructiveChildren

Keywords

Sleep apneaChildrenNeurocognitive

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA)

    Changes from before treatment in neurocognitive score on CUMANIN neuropsychological tests in chilren under 6 years old or ENFEN neuropsychological tests in children over six years old at 1 year after treatment

    2018-2021

Secondary Outcomes (2)

  • Behavior changes after treatment in children with Obstructive Sleep Apnea (OSA)

    2018-2021

  • Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)

    2018-2021

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children from 3 to 12 years-old referred consecutively to the Sleep Units of the participating sites due to clinical suspicion of OSA.

You may qualify if:

  • Children aged 3 to 12 years consecutively referred to the Sleep Units due to clinical suspicion of OSA.

You may not qualify if:

  • A significant medical and/or psychiatric comorbidity that may require urgent treatment (Respiratory Failure, Heart Failure, Cardiac Malformations, tumors, psychiatric type disorders that may require specific treatment…)
  • Craniofacial malformations, deposit diseases and/or malformation syndromes (including Down's syndrome)
  • Already diagnosed neurocognitive type disorders (e.g.: Autism, cerebral palsy, etc.)
  • Attention deficit hyperactivity disorders previously diagnosed according to DSM-IV criteria
  • Girls ≤ 12 with menarche at the time of starting the study
  • Children that refuse to take part in the study (do not sign the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Complejo Asistencial Universitario de Burgos

Burgos, 09005, Spain

RECRUITING

Hospital Universitario de Burgos

Burgos, 09006, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • María Luz Alonso-Alvarez, MD

    Complejo Asistencial Universitario de Burgos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Luz Alonso-Alvarez, MD

CONTACT

34 610246473mlalonso@hubu.es

Joaquin Terán-Santos, MD

CONTACT

34 630028489jtjteran07@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

February 18, 2018

First Posted

May 15, 2019

Study Start

January 1, 2018

Primary Completion

January 31, 2021

Study Completion

December 31, 2023

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

ES(2)