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
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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