Real Life Pediatric Obstructive Sleep Apnea

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients

NCT05421403

Obstructive Sleep Apnea

COMPLETED NA

Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care

NCT02781376

Obstructive Sleep Apnea

COMPLETED NA

Cerebral Blood Flow and Childhood Obstructive Sleep Apnea

NCT02995837

Obstructive Sleep Apnea Syndrome

COMPLETED

Prevalence of Sleep Apnea/Hypopnea Syndrome in Obese Children

NCT01322763

Sleep Apnea Children Obesity

UNKNOWN

A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)

NCT01837459

Obstructive Sleep Apnea

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

SAMPLE SIZE: To evaluate the relationship between cognitive measures and polysomnographic variables and differences before-after treatment, a sample size of 1200 children is calculated.

METHODOLOGY: The followiong will be obtained in all children included in the study: personal medical history, Spanish version of Pediatric Sleep Questionnaire (PSQ), physical and otorhinolaryngological examination, neurocognitive assessment by customary neurocognitive and behavioral tests routinely used in Spain (CUMANIN neuropsychological tests, ENFEN neuropsychological tests, and Spanish version of the ECBI (Eyberg Child Behavior Inventory)), sleep study by polysomnography (PSG) or Respiratory Polygraphy (PR) and blood test.

The diagnosis and treatment of OSAS will be established according to the criteria of the Spanish Consensus Document of OSAS in children.

Depending on the treatment, three groups will be obtained: Group 1: Children with OSAS and adenotonsillar hypertrophy we will perform surgical treatment. Group 2: Children with OSAS and without adenotonsillar hypertrophy will be evaluated other treatments (sleep hygiene-diet and physical activity guidance, medical, orthodontic, continuous positive pressure on the airway (CPAP) treatment, Group 3: regular follow up but no treatment for children referred for suspicion of OSAS and that in PSG or RP the diagnosis of OSAS is not established. In all three groups, at 12 months, we will repeat all assessments as delineated for the initial visit

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No