- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05986487
Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project aims to implement a new hypertension management system, which will include the monitoring and treatment of respiratory disorders during sleep. This new precision medicine-based management will be carried out in the Primary Care setting and will improve blood pressure control, the main risk factor for the leading cause of death worldwide: cardiovascular diseases.
The current model for managing patients with essential hypertension is based on deciding when to treat with measures that go beyond dietary and lifestyle interventions. Once it is decided to treat the patient pharmacologically, the ideal drug is decided and during follow-up whether it is necessary to change the treatment or not. This entire process is usually carried out by the Primary Care doctors. The hypertension specialist is usually reserved for difficult-to-control cases or patients with resistant hypertension. In the current model there is little communication between the different levels of care. In addition, the study of the SDB is carried out completely independently of this process. The METASLEEP project aims to change this work dynamic. The creation of the METASLEEP PC-node centralizes care for patients with hypertension in the Primary Care team (physician and nurse). The PC-node will evaluate the patient comprehensively, incorporating 24-hour ambulatory blood pressure monitoring as well as a sleep study. There will be coordination with the hypertension specialist for the management of complex cases and with the sleep unit specialist to support therapeutic decisions or management of patients with complex sleep apnea. Moreover, our project aims to incorporate the precision medicine techniques, such as the HIPARCO-score in the clinical management of hypertensive patients. Furthermore, the investigators aim to identify the best option that guarantees the best control in different clinical situations, with the greatest anticipation and with the fewest side effects, as well as with the greatest additional benefits and, finally, when to modify the treatment.
The METASLEEP project aims to contribute to the development of personalized medicine tools by identifying the molecular profile that enables to develop a non-invasive model with clinical utility. This model will contribute to the characterization of the patient that is vulnerable to the deleterious effects of OSA and who would benefit from OSA treatment to improve cardiovascular morbidity. The availability of an instrument based on a biomarker profile for risk stratification will help the physician to make therapeutic decisions in individuals with OSA and hypertension, contributing to the change of the current clinical management guidelines. Likewise, molecular tools can be developed to identify the profile of the patient that positively respond to CPAP treatment (in terms of blood pressure decrease). Finally, the investigators will obtain data that will evaluate the economic impact of the METASLEEP project. This cost-effectiveness analysis will be carried out from the perspectives of both, the SNS and the social perspective. Importantly, the investigators have planned a specific objective to define and calculate quantitatively, qualitative and cost-effectively the METASLEEP project, compared to the conventional current procedure.
The overall objective of the METASLEEP project is to establish a new paradigm in the treatment of hypertension through the management of sleep disordered breathing (SDB).
The specific objectives, are the following:
- To implement the management of hypertension based on the presence of nocturnal hypertension and SDB (METASLEEP model).
- To depict a singular cluster of circulating miRNAs (METASLEEP-score) in patients with nocturnal hypertension and SDB.
- To characterize highly responder patients that would benefit from SDB treatment in terms of blood pressure control.
- To implement in the clinical practice the use of the HIPARCO-score technology for the management of resistant hypertension.
- To evaluate the feasibility and acceptability of the METASLEEP model for the comprehensive clinical management of hypertension based in the management of SDB.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ferran Barbé Illa, MD
- Phone Number: +34 973705372
- Email: febarbe.lleida.ics@gencat.cat
Study Contact Backup
- Name: Manuel Sánchez de la Torre, PhD
- Phone Number: +34 973702959
- Email: manuel.sanchez@udl.cat
Study Locations
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-
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Lleida, Spain, 25198
- Recruiting
- Hospital Universitari Arnau de Vilanova
-
Contact:
- Ferran Barbé Illa, MD
- Phone Number: +34 973705372
- Email: febarbe.lleida.ics@gencat.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.
- Signature of the informed consent.
Exclusion Criteria:
- Psycho-physical inability to complete questionnaires.
- Patients with very limiting chronic disease.
- Previous diagnosis of OSA or any other sleeping disorder
- Active treatment with CPAP.
- Fixed night shift worker.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
Patients with nocturnal hypertension and/or non-dipper pattern who undergo a sleep test, obtaining the diagnosis of obstructive sleep apnea, will be treated following the clinical practice standards.
|
CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.
Each participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics.
Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep.
This intervention will help the patient to improve in different aspects of their health.
|
Patients with nocturnal hypertension and/or non-dipper pattern and without OSA
Patients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.
|
Each participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics.
Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep.
This intervention will help the patient to improve in different aspects of their health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in nocturnal blood pressure
Time Frame: At 6 and 18 months
|
Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)
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At 6 and 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
Time Frame: 6 and 18 months
|
Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
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6 and 18 months
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Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization
Time Frame: 6 and 18 months
|
Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment
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6 and 18 months
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Clinic phenotype characterization
Time Frame: 6 months
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Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment
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6 months
|
Changes induced by exosomes
Time Frame: 6 months
|
Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients.
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6 months
|
Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)
Time Frame: 2 years
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Analyse mRNA to validate de HIPARCO score
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2 years
|
Creation of a predictive tool (like HIPARCO-Score) for women
Time Frame: 2 years
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Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.
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2 years
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Cost-Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.
Time Frame: After 18 months of follow-up
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Only direct costs will be considered.
Analysis will include an estimation of quality-adjusted life-years (QALYs) gained
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After 18 months of follow-up
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Validation of the METASLEEP score
Time Frame: 2 years
|
Identify specific miRNAs signature that would have the capability to identify patients with nocturnal hypertension, likely to exhibit a favorable blood pressure response to SDB treatment for the blood pressure control.
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2 years
|
CPAP compliance at 6 and 18 months
Time Frame: 6 and 18 months
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Objective data to be downloaded from the CPAP device
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6 and 18 months
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Satisfaction at 6 and 18 months
Time Frame: 6 and 18 months
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Visual analog scale.
The Satisfaction test is a self-reported outcome measure composed by 3 items which are measured by ten ranges.
Scores range from 0 to 10, with higher scores indicating better satisfaction.
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6 and 18 months
|
Changes in Epworth Sleepiness Scale (ESS)
Time Frame: 6 and 18 months
|
Changes in Epworth Sleepiness Scale (ESS).
The ESS test is a self-reported outcome measure composed by 8 items which examine diurnal somnolence.
Scores range from 0 to 28, with higher scores indicating more sleepines.
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6 and 18 months
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Changes in Quality of life: Test EuroQol
Time Frame: 6 and 18 months
|
Changes in Quality of life: Test EuroQol.
The EuroQol test is a self-reported outcome measure composed by 5 items which examine five dimensions of health (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, some problems or moderate problems, and severe problems).
Scores range from 0 to 1, with higher scores indicating better quality of life
|
6 and 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ferran Barbé Illa, MD, Spanish Respiratory Society (SEPAR)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMP22/00030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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