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| Name | Class |
|---|---|
| University of Guadalajara | OTHER |
| Instituto de Investigación Hospital Universitario La Paz | OTHER |
| Instituto de Investigaciones del Sueño | UNKNOWN |
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There are data supporting a possible increase in the prevalence of High Blood Pressure (HBP) in pediatric patients with Sleep Disorder Breathing (SDB). Adeno-tonsillectomy has proven to be an effective treatment in the correction of nocturnal respiratory events in the majority of patients. Our objective is to determine the presence of HBP in pediatric patients with SDB and the impact of adenotonsillar surgery on its correction. Methodology: 286 children (4-18 years old) will be included consecutively referred for suspected SDB. Variables: a) Clinical history; b) Anthropometric variables: weight, height, body mass index, neck, hip and waist perimeter c) Chervin questionnaire d) polysomnography (PSG) for the SDB assessment and e) for the HBP evaluation, ambulatory blood pressure measurement (ABPM) will be performed during 24h. In control group (not SDB) and patients without treatment, the same tests will be repeated six months after the baseline visit. Patients with indication for medical treatment, ABPM and PSG will be performed 6 months after treatment initiation. In patients with surgery indication, ABPM will be performed just before the surgical treatment and ABPM and PSG six months after the intervention. In a subgroup of patients, it will be also assessed the presence of subclinical organic damage produced by HBP: blood markers (creatinine / glomerular filtration), urine (albuminuria / proteinuria), electrocardiogram and echocardiography (left ventricle hypertrophy).
HYPOTHESIS Sleep Disorder Breathing (SDB) increase the appearance of High Blood Pressure (HBP) in pediatric patients. This HBP is reversible after treatment.
OBJECTIVES
Main goal:
1. Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment.
Secondary objectives:
Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB.
Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
Assess the organic damage produced:
Multicentre, longitudinal, prospective study with control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before treatment | No Intervention | ||
| After treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adenotonsillar surgery | Procedure | when indicated, adenotonsillar surgery for SDB treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean systolic and diastolic blood pressure | Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea index | Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI). | 6 months |
| Percentage of change of mean blood pressure between day and night |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Guadalajara | Guadalajara | Guadalajara | 19002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36553294 | Background | Castillo-Garcia M, Solano-Perez E, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Mediano San Andres R, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Lopez-Duenas A, Fidalgo L, Rodriguez A, Mediano O, Network SS. Prevalence of High Blood Pressure in Pediatric Patients with Sleep-Disordered Breathing, Reversibility after Treatment: The KIDS TRIAL Study Protocol. Children (Basel). 2022 Nov 28;9(12):1849. doi: 10.3390/children9121849. | |
| 42013651 |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| OTHER |
| Hospital General Universitario Santa Lucía | OTHER |
| Hospital Universitario Araba | OTHER |
| Hospital San Pedro de Logroño | OTHER |
The control system of measurements will be before and after treatment on the same group of patients (children with SDB and indication for adeno-tonsillectomy). For the analysis of the main variable (mean systolic blood pressure-BP), baseline values will be obtained through ambulatory blood pressure monitoring (ABPM) in the baseline visit. In order to evaluate the impact of treatment for SDB (adeno-tonsillar surgery) on BP, the measurement will be repeated just before the surgical intervention (ABPM) and six months after surgery (ABPM) in the same group. In this way, a control group will be available (measurements just before the surgery / control group) that will be compared with the measurements of those same patients six months after the surgery (treatment group). This measure allows having control values without preventing the treatment of any patient and without causing delays in the application of the same linked to the study
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To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB
| 6 months |
| blood pressure in clinic | Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM). | 6 months |
| creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy. | Assess the manifestation of subclinical organic damage by means of other markers such as: blood (creatinine / glomerular filtration), urine (albuminuria / proteinuria) and echocardiography (left ventricle hypertrophy). | 6 months |
| Derived |
| Mediano O, Castillo-Garcia M, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Forne C, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Fidalgo L, Rodriguez A, Lopez-Monzoni S, Alvarez A, Pia-Martinez C, Del Rio G, Bragado E, Roncero A, Garcia-Mediano B, Mato-Lopez A, Rodriguez-Perojo A, Pengo MF, Solano-Perez E. Nocturnal blood pressure patterns in pediatric obstructive sleep apnea: The Kids Trial study. Sleep Med. 2026 Aug;144:108957. doi: 10.1016/j.sleep.2026.108957. Epub 2026 Apr 8. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |