Real Life Pediatric Obstructive Sleep Apnea (RELIPOSA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive; Children

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

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: María Luz Alonso-Alvarez, MD; Phone Number: 34 610246473; Email: mlalonso@hubu.es
• Study Contact Backup: Name: Joaquin Terán-Santos, MD; Phone Number: 34 630028489; Email: jtjteran07@gmail.com

Study Locations

• Spain
  • Burgos, Spain, 09006
    • Recruiting
    • Hospital Universitario de Burgos
    • Contact: María Luz Alonso-Alvarez, MD; Phone Number: 34 610246473; Email: mlalonso@hubu.es
    • Contact: Joaquin Terán-Santos, MD; Phone Number: 34 630028489; Email: jtjteran07@gmail.com
  • Burgos, Spain, 09005
    • Recruiting
    • Complejo Asistencial Universitario de Burgos
    • Contact: María Luz Alonso-Alvarez, MD; Phone Number: 34610246473; Email: mlalonso@hgy.es
    • Principal Investigator: Maria Luz Alonso-Alvarez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)	Changes from baseline in sleep study on polysomnography after treatment	2018-2021

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: María Luz Alonso-Alvarez, MD, Complejo Asistencial Universitario de Burgos

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Children; Neurocognitive; Sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PI 084-2016; STGRA17049OSASPAEDS-SH (Other Grant/Funding Number: Philips)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No