🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Spain / NCT05986487
Recruiting Observational

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

NCT05986487 · tracked via the Priya Life Science Spain tracker
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Phase
Observational
Started
2024-04-16
Last updated
2024-12-03

Condition(s) studied

HypertensionObstructive Sleep Apnea

Investigational drug(s) / intervention(s)

CPAP or usual practiceMonitoring and intervention in follow-up

CPAP or usual practice: 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: 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 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari Arnau de Vilanova Lleida Spain Recruiting

More Sociedad Española de Neumología y Cirugía Torácica trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05986487 on ClinicalTrials.gov ↗ ← All trials in Spain