Blood PressureNCT03696654

High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing.

A study testing adenotonsillar surgery in people with Blood Pressure and Sleep-Disordered Breathing, run by Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 4 to 18 years
Conditions the study is for: Blood Pressure, Sleep-Disordered Breathing
What is being tested?: adenotonsillar surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 286 participants
Where: 1 siteSpain
Study dates: 19 Feb 2019to 1 Jan 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario de Guadalajara
Guadalajara, Guadalajara, 19002

Other trials in Spain

About this study

Official title: 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).

Read the 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:

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:

Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB.
Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
Assess the organic damage produced:
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).
Establish the physiopathological mechanisms involved in the HBP / SDB relationship.

Multicentre, longitudinal, prospective study with control group.

POPULATION TO STUDY: Children between 4 and 18 years old prospectively derived for sleep study for suspected SDB.
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).
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.

Conditions: Blood Pressure, Sleep-Disordered Breathing
Being tested: adenotonsillar surgery
Keywords: high blood pressure, adenotonsillectomy, sleep-disordered breathing, sleep apnea, children, cardiovascular risk
Medical subject headings: Sleep Apnea Syndromes, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

adenotonsillar surgeryProcedure or surgery
when indicated, adenotonsillar surgery for SDB treatment

Study groups in NCT03696654
Study group	Role	What they receive
Before treatment	No intervention	Not described
After treatment	Active comparator	Not described Receives: Procedure: adenotonsillar surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean systolic and diastolic blood pressure
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
Measured: 6 months

Secondary outcomes (4)

Apnea hypopnea index
Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
Measured: 6 months
Percentage of change of mean blood pressure between day and night
To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB
Measured: 6 months
blood pressure in clinic
Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
Measured: 6 months
creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.
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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 20191 Jan 2026

First posted5 Oct 2018
Study start19 Feb 2019
Primary completion1 Jan 2026 (estimated)
Study completion1 Jan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Model description: The control system of measurements will be before and after treatment on the same group of patients (children with SDB and indication for adeno-tonsillectomy). For the analysis of the main variable (mean systolic blood pressure-BP), baseline values will be obtained through ambulatory blood pressure monitoring (ABPM) in the baseline visit. In order to evaluate the impact of treatment for SDB (adeno-tonsillar surgery) on BP, the measurement will be repeated just before the surgical intervention (ABPM) and six months after surgery (ABPM) in the same group. In this way, a control group will be available (measurements just before the surgery / control group) that will be compared with the measurements of those same patients six months after the surgery (treatment group). This measure allows having control values without preventing the treatment of any patient and without causing delays in the application of the same linked to the study
Masking: None (open label)
Enrolment: 286 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03696654
Sponsor's protocol ID: adm00064
Status last verified: Feb 2025
First submitted: 3 Oct 2018
Last updated: 8 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Castillo-Garcia M, Solano-Perez E, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Mediano San Andres R, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Lopez-Duenas A, Fidalgo L, Rodriguez A, Mediano O, Network SS. Prevalence of High Blood Pressure in Pediatric Patients with Sleep-Disordered Breathing, Reversibility after Treatment: The KIDS TRIAL Study Protocol. Children (Basel). 2022 Nov 28;9(12):1849. doi: 10.3390/children9121849.
PubMed 36553294
Mediano O, Castillo-Garcia M, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Forne C, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Fidalgo L, Rodriguez A, Lopez-Monzoni S, Alvarez A, Pia-Martinez C, Del Rio G, Bragado E, Roncero A, Garcia-Mediano B, Mato-Lopez A, Rodriguez-Perojo A, Pengo MF, Solano-Perez E. Nocturnal blood pressure patterns in pediatric obstructive sleep apnea: The Kids Trial study. Sleep Med. 2026 Aug;144:108957. doi: 10.1016/j.sleep.2026.108957. Epub 2026 Apr 8.
PubMed 42013651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).
ClinicalTrials.gov ID: NCT03696654
Acronym / sponsor ID: adm00064
Conditions: Blood Pressure, Sleep-Disordered Breathing
Keywords: high blood pressure, adenotonsillectomy, sleep-disordered breathing, sleep apnea, children, cardiovascular risk
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 286 participants (estimated)
Lead sponsor: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la IntegracionUniversity, hospital or other
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
Study start: 19 Feb 2019 (actual)
Primary completion: 1 Jan 2026 (estimated)
Study completion: 1 Jan 2026 (estimated)
First posted: 5 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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:

Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).
To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB.
Establish the correlation between the diagnosis of HBP measured in the clinic and ambulatory blood pressure measurement (ABPM).
Assess the organic damage produced:
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).
Establish the physiopathological mechanisms involved in the HBP / SDB relationship.

Multicentre, longitudinal, prospective study with control group.

POPULATION TO STUDY: Children between 4 and 18 years old prospectively derived for sleep study for suspected SDB.
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).
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 design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: The control system of measurements will be before and after treatment on the same group of patients (children with SDB and indication for adeno-tonsillectomy). For the analysis of the main variable (mean systolic blood pressure-BP), baseline values will be obtained through ambulatory blood pressure monitoring (ABPM) in the baseline visit. In order to evaluate the impact of treatment for SDB (adeno-tonsillar surgery) on BP, the measurement will be repeated just before the surgical intervention (ABPM) and six months after surgery (ABPM) in the same group. In this way, a control group will be available (measurements just before the surgery / control group) that will be compared with the measurements of those same patients six months after the surgery (treatment group). This measure allows having control values without preventing the treatment of any patient and without causing delays in the application of the same linked to the study

Arm	Type	Receives
Before treatment	No intervention	–
After treatment	Active comparator	Procedure: adenotonsillar surgery

Who may qualify

Ages: 4 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
adenotonsillar surgerywhen indicated, adenotonsillar surgery for SDB treatment	Procedure or surgery	After treatment

Primary outcome

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

4 secondary outcomes

Apnea hypopnea index
Time frame: 6 months
Percentage of change of mean blood pressure between day and night
Time frame: 6 months
blood pressure in clinic
Time frame: 6 months
creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Background: PubMed 36553294Castillo-Garcia M, Solano-Perez E, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Mediano San Andres R, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Lopez-Duenas A, Fidalgo L, Rodriguez A, Mediano O, Network SS. Prevalence of High Blood Pressure in Pediatric Patients with Sleep-Disordered Breathing, Reversibility after Treatment: The KIDS TRIAL Study Protocol. Children (Basel). 2022 Nov 28;9(12):1849. doi: 10.3390/children9121849.
Derived from this study: PubMed 42013651Mediano O, Castillo-Garcia M, Romero-Peralta S, Viejo-Ayuso ME, Silgado-Martinez L, Alvarez-Balado L, Forne C, Resano-Barrio P, Garcia-Rio F, Cano-Pumarega I, Sanchez-de-la-Torre M, Ortigado A, Fidalgo L, Rodriguez A, Lopez-Monzoni S, Alvarez A, Pia-Martinez C, Del Rio G, Bragado E, Roncero A, Garcia-Mediano B, Mato-Lopez A, Rodriguez-Perojo A, Pengo MF, Solano-Perez E. Nocturnal blood pressure patterns in pediatric obstructive sleep apnea: The Kids Trial study. Sleep Med. 2026 Aug;144:108957. doi: 10.1016/j.sleep.2026.108957. Epub 2026 Apr 8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean systolic and diastolic blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696654, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.