Real Life Pediatric Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— RELIPOSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950466
• Other study ID #: PI 084-2016
• Secondary ID: STGRA17049OSASPA
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2019
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: María Luz Alonso-Alvarez, MD
• Phone: 34 610246473
• Email: mlalonso[@]hubu.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Children
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de Burgos	Burgos
Spain	Hospital Universitario de Burgos	Burgos

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Philips Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Behavior changes after treatment in children with Obstructive Sleep Apnea (OSA)	Changes from before treatment in behavior score on ECBI (Eyberg Child Behavior Inventory) at 1 year after treatment	2018-2021
Secondary	Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)	Changes from baseline in sleep study on polysomnography after treatment	2018-2021