High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

NCT03696654 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-08-08

No results posted yet for this study

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

Interventions

PROCEDURE

adenotonsillar surgery

when indicated, adenotonsillar surgery for SDB treatment

Sponsors & Collaborators

  • Hospital General Universitario de Guadalajara

    collaborator UNKNOWN
  • Instituto de Investigación Hospital Universitario La Paz

    collaborator OTHER
  • Instituto de Investigaciones del Sueño

    collaborator UNKNOWN
  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    collaborator OTHER
  • Hospital General Universitario Santa Lucía

    collaborator OTHER
  • Hospital Universitario Araba

    collaborator OTHER
  • Hospital San Pedro de Logroño

    collaborator OTHER
  • Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696654 on ClinicalTrials.gov