NCT05986487 Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project
| NCT ID | NCT05986487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sociedad Española de Neumología y Cirugía Torácica |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,523 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,523 participants in total. It began in 2024-04-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ferran Barbé Illa, MD
PRINCIPAL INVESTIGATOR
Spanish Respiratory Society (SEPAR)
Frequently Asked Questions
Who can join the NCT05986487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05986487 currently recruiting?
Yes, NCT05986487 is actively recruiting participants. Contact the research team at febarbe.lleida.ics@gencat.cat for enrollment information.
Where is the NCT05986487 trial being conducted?
This trial is being conducted at Lleida, Spain.
Who is sponsoring the NCT05986487 clinical trial?
NCT05986487 is sponsored by Sociedad Española de Neumología y Cirugía Torácica. The principal investigator is Ferran Barbé Illa, MD at Spanish Respiratory Society (SEPAR). The trial plans to enroll 1,523 participants.