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

NCT05986487 | Recruiting

• 1 other identifier: PMP22/00030
• Study Type: observational
• Target: 1,523
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Changes in nocturnal blood pressure

  Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)

  At 6 and 18 months

Secondary Outcomes (12)

• Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.

  6 and 18 months

• Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization

  6 and 18 months

• Clinic phenotype characterization

  6 months

• Changes induced by exosomes

  6 months

• Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)

  2 years

Study Arms (2)

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.

Device: CPAP or usual practice; Device: 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.

Device: Monitoring and intervention in follow-up

Interventions

CPAP or usual practice DEVICE

CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.

Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA

Monitoring and intervention in follow-up DEVICE

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.

Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA; Patients with nocturnal hypertension and/or non-dipper pattern and without OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients atttending to their primary care center for the control of their arterial hypertension.

You may qualify if:

• Patients with arterial hypertension who visit their primary care physician in one of the participating primary care centers.
• Signature of the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Related Publications (1)

• Pinilla L, Benitez ID, Moncusi-Moix A, Torres G, Casanovas-Salvatella O, Juez-Garcia I, Gracia-Lavedan E, Alonso-Fernandez A, Caballero-Eraso C, Cano-Pumarega I, Boira I, Egea C, Gonzalez M, Mediano O, Roncero A, Roche-Campo F, Sanchez-Quiroga MA, Chai-Coetzer CL, Sanchez-de-la-Torre M, Barbe F, de Batlle J; Spanish Sleep Network. Impact of Sleep-disordered Breathing Management in Primary Care on Systemic Hypertension Control: Protocol for the METASLEEP Implementation Trial. Open Respir Arch. 2025 Nov 17;8(1):100522. doi: 10.1016/j.opresp.2025.100522. eCollection 2026 Jan-Mar.

  PMID: 41477672 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* 2 tubes EDTA (6 ml) * 2 tubes with separating gel for serum (6 ml) * 1 tempus RNA tube (2,5 ml) * 1 tube for urine and urine sediment (3 ml)

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Methods

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Investigative Techniques

Study Officials

• Ferran Barbé Illa, MD

  Spanish Respiratory Society (SEPAR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferran Barbé Illa, MD

CONTACT

+34 973705372; febarbe.lleida.ics@gencat.cat

Manuel Sánchez de la Torre, PhD

CONTACT

+34 973702959; manuel.sanchez@udl.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Respiratory Medicine

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: April 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)