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HypertensionNCT05986487

Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project

An observational study of Hypertension and Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Obstructive Sleep Apnea
What is being tested?
CPAP or usual practice and Monitoring and intervention in follow-up
Type of treatment
Medical device
How many people
1,523 participants
Where
1 siteSpain
Study dates
16 Apr 2024to Dec 2025
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients atttending to their primary care center for the control of their arterial hypertension.

Who may be able to join

  • Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.
  • Signature of the informed consent.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ferran Barbé Illa, MD contact

+34 973705372

febarbe.lleida.ics@gencat.cat

Manuel Sánchez de la Torre, PhD contact

+34 973702959

manuel.sanchez@udl.cat

Spain1 site, 1 recruiting
  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Ferran Barbé Illa, MD, +34 973705372, febarbe.lleida.ics@gencat.cat

    Recruiting

Other trials in Spain

About this study

Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly supported by the extensively available scientific evidence. Targeting sleep is considered the new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages consideration of including sleep disturbances in the top 10 potentially modifiable cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with hypertension. The personalized management of hypertension is challenging due to; i) the misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk factor for hypertension. Importantly, the investigators already made the seminal observations showing that the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive phenotypes with the highest mortality risk. Given the need for novel strategies to treat hypertension and, supported by our data, the investigators propose to study and treat sleep-disordered breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art providing a new paradigm for the accurate hypertension classification and treatment. This project will open up a new avenue on the therapeutic potential of the management of sleep-disordered breathing in hypertension.

Read the 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:

  1. To implement the management of hypertension based on the presence of nocturnal hypertension and SDB (METASLEEP model).
  2. To depict a singular cluster of circulating miRNAs (METASLEEP-score) in patients with nocturnal hypertension and SDB.
  3. To characterize highly responder patients that would benefit from SDB treatment in terms of blood pressure control.
  4. To implement in the clinical practice the use of the HIPARCO-score technology for the management of resistant hypertension.
  5. To evaluate the feasibility and acceptability of the METASLEEP model for the comprehensive clinical management of hypertension based in the management of SDB.
Being tested
CPAP or usual practice, Monitoring and intervention in follow-up
Medical subject headings
Hypertension, Sleep Apnea, Obstructive

What participants receive

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

  • CPAP or usual practiceDevice

    CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.

  • Monitoring and intervention in follow-upDevice

    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.

Study groups in NCT05986487
Study groupRoleWhat they receive
Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSAPatients 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.
Receives: Device: CPAP or usual practice; Device: Monitoring and intervention in follow-up
Patients with nocturnal hypertension and/or non-dipper pattern and without OSAPatients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.
Receives: Device: Monitoring and intervention in follow-up

What is being measured

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

  1. Changes in nocturnal blood pressure

    Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)

    Measured: At 6 and 18 months

Secondary outcomes (12)
  1. Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.

    Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.

    Measured: 6 and 18 months

  2. Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization

    Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment

    Measured: 6 and 18 months

  3. Clinic phenotype characterization

    Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment

    Measured: 6 months

  4. Changes induced by exosomes

    Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients.

    Measured: 6 months

  5. Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)

    Analyse mRNA to validate de HIPARCO score

    Measured: 2 years

  6. Creation of a predictive tool (like HIPARCO-Score) for women

    Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.

    Measured: 2 years

  7. 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.

    Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained

    Measured: After 18 months of follow-up

  8. Validation of the METASLEEP score

    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.

    Measured: 2 years

  9. CPAP compliance at 6 and 18 months

    Objective data to be downloaded from the CPAP device

    Measured: 6 and 18 months

  10. Satisfaction at 6 and 18 months

    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.

    Measured: 6 and 18 months

  11. Changes in Epworth Sleepiness Scale (ESS)

    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.

    Measured: 6 and 18 months

  12. Changes in Quality of life: Test EuroQol

    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

    Measured: 6 and 18 months

Timeline

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

  1. First posted14 Aug 2023
  2. Study start16 Apr 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,523 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986487
Sponsor's protocol ID
PMP22/00030
Status last verified
Nov 2024
First submitted
3 Aug 2023
Last updated
3 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pinilla L, Benitez ID, Moncusi-Moix A, Torres G, Casanovas-Salvatella O, Juez-Garcia I, Gracia-Lavedan E, Alonso-Fernandez A, Caballero-Eraso C, Cano-Pumarega I, Boira I, Egea C, Gonzalez M, Mediano O, Roncero A, Roche-Campo F, Sanchez-Quiroga MA, Chai-Coetzer CL, Sanchez-de-la-Torre M, Barbe F, de Batlle J; Spanish Sleep Network. Impact of Sleep-disordered Breathing Management in Primary Care on Systemic Hypertension Control: Protocol for the METASLEEP Implementation Trial. Open Respir Arch. 2025 Nov 17;8(1):100522. doi: 10.1016/j.opresp.2025.100522. eCollection 2026 Jan-Mar.

    PubMed 41477672

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. 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?

Contact Ferran Barbé Illa, MD (+34 973705372, febarbe.lleida.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in nocturnal blood pressure (time frame: At 6 and 18 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 NCT05986487, which also lists 1 linked publication.

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 3 Dec 2024.

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