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).

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) and pulse transit time (PTT) will be performed during 24h. In control group (not SDB) and patients with indication for medical treatment, the same tests will be repeated six months after the baseline visit. In patients with surgery indication, ABPM and PTT will be performed just before the surgical treatment and ABPM, PTT and PSG six months after the intervention. In a subgroup of patients, will also assess 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: Unknown
• Conditions: Blood Pressure; Sleep Disorder; Breathing-Related
• Intervention / Treatment: Procedure: adenotonsillar surgery

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.
5. Validate the pulse transit time (PTT) measurement as arterial pressure monitoring.

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 / PTT (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) with pulse transit time measurement (PTT). 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 0-3 / h; Group II: AHI 3-5 / h; group III AHI> 5 / 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) and PTT 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, PTT, PSG and tests of organic damage if applicable). In the case of patients referred for adenotonsillar surgery, the procedures will be repeated just before the intervention (ABPM and PTT) and six months after the intervention (ABPM, PTT, 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: Interventional
• Enrollment (Anticipated): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Mediano, MD; Phone Number: +34 678634778; Email: olgamediano@hotmail.com

Study Locations

• Spain
  • Guadalajara, Spain, 19002
    • Recruiting
    • Hospital Universitario de Guadalajara
    • Contact: Olga Mediano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 / PTT (arrhythmias, latex allergy or coagulation disease).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean systolic 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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index	Establish the relationship between the presence of hypertension and the severity of SDB (apnea-hypopnea index-AHI, desaturation index-DI).	6 months
Percentage of change of mean systolic blood pressure between day and night	To evaluate the variability along the circadian rhythm of the HBP patterns produced in pediatric patients with SDB	6 months
blood pressure in clinic	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.	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
Pulse transit time	Validate the pulse transit time (PTT) measurement as arterial pressure monitoring.	6 months

Collaborators and Investigators

• Sponsor: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
• Collaborators: Instituto de Investigación Hospital Universitario La Paz; Hospital General Universitario Santa Lucia; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Hospital Universitario de Burgos; Hospital General Universitario de Guadalajara; Instituto de Investigaciones del Sueño

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Hypertension; Sleep Wake Disorders; Respiratory Aspiration; Parasomnias
• Other Study ID Numbers: adm00064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No