NCT05986487Recruiting
Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1523 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 16 Apr 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Diseases
- High blood pressure
- NCT number
- NCT05986487
What you commit to
- Study type: Observational
- Planned participants: 1523
- From 16 Apr 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of OSA or any other sleeping disorder
- Active treatment with CPAP.
Other illness
- Patients with very limiting chronic disease.
Other
- Psycho-physical inability to complete questionnaires.
- Fixed night shift worker.
Who the study is looking for
- Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.
- Signature of the informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
Related publications
- Impact of Sleep-disordered Breathing Management in Primary Care on Systemic Hypertension Control: Protocol for the METASLEEP Implementation Trial.Open Respir Arch · 2026 · PMID 41477672
This page is information, not medical advice. Discuss any trial with your doctor.