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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociedad Española de Neumología y Cirugía Torácica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Signature of the informed consent.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CPAP or usual practice

    Device

    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-up

    Device

    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.

Treatment groups

1,523 Participants
are divided into 2 treatment groups
Group A: Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA2 interventions
Group B: Patients with nocturnal hypertension and/or non-dipper pattern and without OSA1 intervention

Trial outcomes

Primary outcomes

1

Changes in nocturnal blood pressure

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

Time frame
At 6 and 18 months

Secondary outcomes

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.

Time frame
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

Time frame
6 and 18 months
3

Clinic phenotype characterization

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

Time frame
6 months
4

Changes induced by exosomes

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

Time frame
6 months

Other outcomes

Sponsors and contacts

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