Clinical trial NCT03950466: Real Life Pediatric Obstructive Sleep Apnea
Official title: OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN: HEALTH AND NEUROCOGNITIVE IMPACT. Real Life Pediatric Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
Children
Keywords: Sleep apnea
Children
Neurocognitive
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2019-05-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA)
timeFrame: 2018-2021
Secondary outcomes:
measure: Behavior changes after treatment in children with Obstructive Sleep Apnea (OSA)
timeFrame: 2018-2021
measure: Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)
timeFrame: 2018-2021
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Complejo Asistencial Universitario de Burgos
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
Study officials:
affiliation: Complejo Asistencial Universitario de Burgos
name: María Luz Alonso-Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References: