Real Life Pediatric Obstructive Sleep Apnea
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Children
- Sleep Apnea - Obstructive
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 3 years and 12 years
- Gender
- Both males and females
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 calc...
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
Tracking Information
- NCT #
- NCT03950466
- Collaborators
- Philips Healthcare
- Investigators
- Principal Investigator: María Luz Alonso-Alvarez, MD Complejo Asistencial Universitario de Burgos