High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

NCT03696654 | Active Not Recruiting DMC

• 1 other identifier: adm00064
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Blood Pressure; Sleep-Disordered Breathing

Keywords

high blood pressure; adenotonsillectomy; sleep-disordered breathing; sleep apnea; children; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Apnea hypopnea index

  6 months

• Percentage of change of mean blood pressure between day and night

  6 months

• blood pressure in clinic

  6 months

• creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.

  6 months

Study Arms (2)

Before treatment

NO INTERVENTION

After treatment

ACTIVE COMPARATOR

Procedure: adenotonsillar surgery

Interventions

adenotonsillar surgery PROCEDURE

when indicated, adenotonsillar surgery for SDB treatment

After treatment

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Approval of the Ethics and Clinical Trials Committee
• Informed consent signed by the parents and / or guardians
• Children from 4 to 18 years old assessed consecutively due to SDB suspicion.

You may not qualify if:

• Associated comorbidities: Cardiovascular (including cardiac malformation), cerebrovascular or severe unstable respiratory disease that makes it impossible to complete the studies
• Genetic diseases
• Children with chronic insomnia and / or depressive syndrome
• Children with malformation syndromes (including craniofacial malformations), Down syndrome, and neuromuscular diseases
• Previous otorhinolaryngologic surgery and / or CPAP treatment
• Contraindication for the realization of the ABPM (arrhythmias, latex allergy or coagulation disease).

Sponsors & Collaborators

• Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion: lead
• Hospital General Universitario de Guadalajara: collaborator
• Instituto de Investigación Hospital Universitario La Paz: collaborator
• Instituto de Investigaciones del Sueño: collaborator
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Hospital General Universitario Santa Lucía: collaborator
• Hospital Universitario Araba: collaborator
• Hospital San Pedro de Logroño: collaborator

Study Sites (1)

Hospital Universitario de Guadalajara

Guadalajara, Guadalajara, 19002, Spain

Location

Related Publications (1)

• 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.

  PMID: 36553294 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypertension

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: February 19, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)