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Taking people in SpainNo phase

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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