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临床试验/NCT03950466
NCT03950466Unknown不适用

OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN: HEALTH AND NEUROCOGNITIVE IMPACT. Real Life Pediatric Obstructive Sleep Apnea

Sociedad Española de Neumología y Cirugía Torácica2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
2
主要终点
Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 2018-2021

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

次要结局

  • 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)

研究者

发起方
Sociedad Española de Neumología y Cirugía Torácica
申办方类型
Other
责任方
Principal Investigator
主要研究者

ML Alonso-Alvarez

Principal Investigator, Medical Doctor

Sociedad Española de Neumología y Cirugía Torácica

研究点 (2)

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