Sleep Apnea, ObstructiveRELIPOSANCT03950466
Real Life Pediatric Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive and Children, run by Sociedad Española de Neumología y Cirugía Torácica at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Children
- How many people
- 1,200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Child
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.
Who may be able to join
- Children aged 3 to 12 years consecutively referred to the Sleep Units due to clinical suspicion of OSA.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Complejo Asistencial Universitario de Burgos
Burgos, 09005
María Luz Alonso-Alvarez, MD, 34610246473, mlalonso@hgy.es
Maria Luz Alonso-Alvarez, MD
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
María Luz Alonso-Alvarez, MD, 34 610246473, mlalonso@hubu.es
Joaquin Terán-Santos, MD, 34 630028489, jtjteran07@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Apnea, Obstructive, Children
- Keywords
- Sleep apnea, Children, Neurocognitive
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2018-2021
Secondary outcomes (2)
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
Measured: 2018-2021
Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)
Changes from baseline in sleep study on polysomnography after treatment
Measured: 2018-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jan 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, ML Alonso-Alvarez, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- María Luz Alonso-Alvarez, MD, Principal investigator, Complejo Asistencial Universitario de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950466
- Sponsor's protocol ID
- PI 084-2016
- Other IDs
- STGRA17049OSASPAEDS-SH
- Acronym
- RELIPOSA
- Status last verified
- May 2019
- First submitted
- 18 Feb 2018
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSTRUCTIVE SLEEP APNEA SYNDROME IN CHILDREN: HEALTH AND NEUROCOGNITIVE IMPACT. Real Life Pediatric Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03950466
- Acronym / sponsor ID
- RELIPOSA / PI 084-2016
- Conditions
- Sleep Apnea, Obstructive, Children
- Keywords
- Sleep apnea, Children, Neurocognitive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children aged 3 to 12 years consecutively referred to the Sleep Units due to clinical suspicion of OSA.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Behavior changes after treatment in children with Obstructive Sleep Apnea (OSA)
Time frame: 2018-2021
Sleep changes after treatment in children with Obstructive Sleep Apnea(OSA)
Time frame: 2018-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Luz Alonso-Alvarez, MD principal investigator
Complejo Asistencial Universitario de Burgos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Children, run by Sociedad Española de Neumología y Cirugía Torácica at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Luz Alonso-Alvarez, MD (34 610246473, mlalonso@hubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive changes after treatment in children with Obstructive Sleep Apnea (OSA) (time frame: 2018-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.