Studies sleep breathing problems in people with high blood pressure
Observes whether treating sleep-disordered breathing affects blood pressure control in adults with hypertension.
Key facts
- Who runs it
- Sociedad Española de Neumología y Cirugía Torácica
- Where
- Lleida, SpainSee the site
- Trial code
- Registry title
- Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project
- Status
- Recruiting
- People taking part
- 1,523 people, planned
- Started
- 16 Apr 2024
- Planned end
- Dec 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- CPAP or usual practice
- Monitoring and intervention in follow-up
- Record updated
- 3 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood pressure who see their primary care doctor at a taking part centre. It studies sleep breathing problems and blood pressure control.
- Age
- 18 Years and older
- Sex
- All sexes can join.
- Disease stage
- Arterial hypertension (high blood pressure).
- Earlier treatment
- People with active CPAP treatment cannot join.
Main reasons for not taking part
- Cannot complete questionnaires because of physical or mental limits
- Very limiting chronic disease
- Earlier diagnosis of sleep apnoea (OSA) or another sleep disorder
- Active CPAP treatment
- Fixed night shift work
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers
- Signature of the informed consent
Who cannot take part
- Previous diagnosis of OSA or any other sleeping disorder
- Active treatment with CPAP
- Patients with very limiting chronic disease
- Psycho-physical inability to complete questionnaires
- Fixed night shift worker
Where in Spain
- Hospital Universitari Arnau de VilanovaLleida, SpainContact: Ferran Barbé Illa, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
Patients with nocturnal hypertension and/or non-dipper pattern who undergo a sleep test, obtaining the diagnosis of obstructive sleep apnea, will be treated following the clinical practice standards.
Treatment: CPAP or usual practice and Monitoring and intervention in follow-up
- Patients with nocturnal hypertension and/or non-dipper pattern and without OSA
Patients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.
Treatment: Monitoring and intervention in follow-up
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project
- Plain-language title
- Studies sleep breathing problems in people with high blood pressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Record updated
- 3 December 2024