NCT03696654Active, not recruiting
High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.
Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).
Source: ClinicalTrials.gov · Last updated 8 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 3 Oct 2018
- Start date
- 19 Feb 2019
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
- Diseases
- High blood pressure
- NCT number
- NCT03696654
What you commit to
- Study type: Interventional
- Planned participants: 286
- From 19 Feb 2019 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous otorhinolaryngologic surgery and / or CPAP treatment
Other illness
- 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
- Contraindication for the realization of the ABPM (arrhythmias, latex allergy or coagulation disease).
Who the study is looking for
- 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.
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.