High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

August 5, 2025 updated by: OlgaMediano, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

HYPOTHESIS Sleep Disorder Breathing (SDB) increase the appearance of High Blood Pressure (HBP) in pediatric patients. This HBP is reversible after treatment.

OBJECTIVES

Main goal:

1. 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.

Secondary objectives:

  1. Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
  2. To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB.
  3. Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).

  4. Assess the organic damage produced:

    1. Assess the manifestation of subclinical organic damage by means of other markers such as: blood (creatinine / glomerular filtration), urine (albuminuria / proteinuria) and echocardiography (left ventricle hypertrophy).
    2. Establish the physiopathological mechanisms involved in the HBP / SDB relationship.

Multicentre, longitudinal, prospective study with control group.

  1. POPULATION TO STUDY: Children between 4 and 18 years old prospectively derived for sleep study for suspected SDB.
  2. Inclusion Criteria: 1) Approval of the Ethics and Clinical Trials Committee 2) Informed consent signed by the parents and / or guardians 3) Children from 4 to 18 years old assessed consecutively due to Sleep Disorders Breathing (SDB) suspicion. Exclusion criteria: 1) Associated comorbidities: Cardiovascular (including cardiac malformation), cerebrovascular or severe unstable respiratory disease that makes it impossible to complete the studies 2) Genetic diseases 3) Children with chronic insomnia and / or depressive syndrome. 4) Children with malformation syndromes (including craniofacial malformations), Down syndrome, and neuromuscular diseases 5) previous otorhinolaryngologic surgery and / or continuous positive airway pressure (CPAP) treatment 6) Contraindication for the realization of the ABPM (arrhythmias, latex allergy or coagulation disease).
  3. METHODOLOGY: All children evaluated for suspected SDB will be offered to participate in the proposed research study, once the inclusion and exclusion criteria have been reviewed. Previous informed consent of their parents, a sleep study will be carried out (complete polysomnography-PSG). The night of the sleep study will be provided to parents the Chervin questionnaire for the collection of clinical data and anthropometric measurements (weight, height; body mass index; percentiles; hip perimeter; waist circumference; neck perimeter) (V1). From the results of the sleep study four groups will be created according to the severity of the SDB measured by the apnea-hypopnea index (AHI): group I: AHI < 3 / h; Group II: AHI ≥ 3 < 5 / h; group III AHI ≥ 5 < 10 / h; Group IV: AHI ≥ 10 / h. For the study of HBP, arterial pressure will be measured in clinic and 24h ambulatory blood pressure measurement (ABPM) in a maximum time of 15 days around the completion of the sleep study (V2) (BP measures according to the regulations European 2016 collected in the study manual of procedure). All patients will be offered voluntary participation in the determination of organic subclinical damage related to HBP and pathophysiological mechanisms involved, which will include the following determinations: blood sample extraction, urine analysis, electrocardiogram and thoracic echocardiography. All organic damage tests will be carried out within a maximum period of one month around the completion of each sleep study. Once the sleep study is done, the therapeutic decision will be made in the pediatric office according to the criteria established in the regulation of sleep respiratory disorders in children SEPAR (V3) (Alonso ML et al. Arch Bronchoneumol 2011, Consensus document of the apnea-hypopnea syndrome during sleep in children). In order to evaluate the impact of treatment of SDB on HBP, measurements will be repeated after treatment (V4). In the case of patients who do not require treatment or who are referred for medical treatment tests will be repeated 6 months after the therapeutic decision making ABPM, PSG and tests of organic damage if applicable. In the case of patients referred for adenotonsillar surgery, ABPM will be repeated just before the intervention and six months after the intervention (ABPM, PSG and proof of organic damage if applicable). In this way, a control group will be available without denying treatment to any of the patients and without allowing delays in the application of the same linked with the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Before treatment
Active Comparator: After treatment
Procedure: adenotonsillar surgery
when indicated, adenotonsillar surgery for SDB treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean systolic and diastolic blood pressure
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Apnea hypopnea index
Time Frame: 6 months
Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
6 months
blood pressure in clinic
Time Frame: 6 months
Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
6 months
creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.
Time Frame: 6 months
Assess the manifestation of subclinical organic damage by means of other markers such as: blood (creatinine / glomerular filtration), urine (albuminuria / proteinuria) and echocardiography (left ventricle hypertrophy).
6 months
Percentage of change of mean blood pressure between day and night
Time Frame: 6 months
To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigación Hospital Universitario La Paz
Hospital General Universitario Santa Lucia
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital Universitario Araba
Hospital General Universitario de Guadalajara
Instituto de Investigaciones del Sueño
Hospital San Pedro de Logroño

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • adm00064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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