RecruitingNCT05986487

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


Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Enrollment

1,523 participants

Start Date

Apr 16, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria5

  • 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.

Interventions

DEVICECPAP or usual practice

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

DEVICEMonitoring and intervention in follow-up

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.


Locations(1)

Hospital Universitari Arnau de Vilanova

Lleida, Spain

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NCT05986487


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