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Real Life Pediatric Obstructive Sleep Apnea (RELIPOSA)
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.
| Condition or disease |
|---|
| Sleep Apnea, Obstructive Children |
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 |
| Estimated Enrollment : | 1200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN: HEALTH AND NEUROCOGNITIVE IMPACT. Real Life Pediatric Obstructive Sleep Apnea |
| Actual Study Start Date : | January 1, 2018 |
| Estimated Primary Completion Date : | January 31, 2021 |
| Estimated Study Completion Date : | December 31, 2023 |
- Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA) [ Time Frame: 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
- Behavior changes after treatment in children with Obstructive Sleep Apnea (OSA) [ Time Frame: 2018-2021 ]Changes from before treatment in behavior score on ECBI (Eyberg Child Behavior Inventory) at 1 year after treatment
- Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA) [ Time Frame: 2018-2021 ]Changes from baseline in sleep study on polysomnography after treatment
| Ages Eligible for Study: | 3 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
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
| Contact: María Luz Alonso-Alvarez, MD | 34 610246473 | mlalonso@hubu.es | |
| Contact: Joaquin Terán-Santos, MD | 34 630028489 | jtjteran07@gmail.com |
| Spain | |
| Complejo Asistencial Universitario de Burgos | Recruiting |
| Burgos, Spain, 09005 | |
| Contact: María Luz Alonso-Alvarez, MD 34610246473 mlalonso@hgy.es | |
| Principal Investigator: Maria Luz Alonso-Alvarez, MD | |
| Hospital Universitario de Burgos | Recruiting |
| Burgos, Spain, 09006 | |
| Contact: María Luz Alonso-Alvarez, MD 34 610246473 mlalonso@hubu.es | |
| Contact: Joaquin Terán-Santos, MD 34 630028489 jtjteran07@gmail.com | |
| Principal Investigator: | María Luz Alonso-Alvarez, MD | Complejo Asistencial Universitario de Burgos |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | February 18, 2018 | ||||||||
| First Posted Date | May 15, 2019 | ||||||||
| Last Update Posted Date | May 15, 2019 | ||||||||
| Actual Study Start Date | January 1, 2018 | ||||||||
| Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA) [ Time Frame: 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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Real Life Pediatric Obstructive Sleep Apnea | ||||||||
| Official Title | OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN: HEALTH AND NEUROCOGNITIVE IMPACT. Real Life Pediatric Obstructive Sleep Apnea | ||||||||
| 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. |
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| 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 |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 3 Years to 12 Years (Child) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Spain | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03950466 | ||||||||
| Other Study ID Numbers | PI 084-2016 STGRA17049OSASPAEDS-SH ( Other Grant/Funding Number: Philips ) |
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| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | ML Alonso-Alvarez, Sociedad Española de Neumología y Cirugía Torácica | ||||||||
| Study Sponsor | Sociedad Española de Neumología y Cirugía Torácica | ||||||||
| Collaborators | Philips Healthcare | ||||||||
| Investigators |
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| PRS Account | Sociedad Española de Neumología y Cirugía Torácica | ||||||||
| Verification Date | May 2019 | ||||||||
