Clinical Trial

High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

Active, Not Recruiting
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Record status
This record was last updated August 8, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2018-10-03; most recent amendment 2025-08-05.
Status change: Recruiting → Active, Not Recruiting 2025-08-05
Status change: Not Yet Recruiting → Recruiting 2020-01-13
Trial Details
NCT Number NCT03696654
Lead Sponsor Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
Collaborators: University of Guadalajara, Instituto de Investigación Hospital Universitario La Paz, Instituto de Investigaciones del Sueño, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital General Universitario Santa Lucía, Hospital Universitario Araba, Hospital San Pedro de Logroño
Conditions Blood Pressure, Sleep-Disordered Breathing
Enrollment 286 participants
Start Date 2019-02-19
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-08