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Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

RecruitingNAAges 18 Years - 100 YearsAllSociedad Española de Neumología y Cirugía Torácica
NCT03948373 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collecti

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Men and women over 18 years of age 2. Referred to the sleep unit for suspected OSA 3. Being normotensive and presenting an AHI ≥ 30 in the sleep study 4. Signature of the informed consent. Exclusion Criteria: 1. Previous CPAP treatment 2. Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18 3. Psychophysical inability to complete questionnaires 4. Previous diagnosis or suspicion of another sleep disorder 5. Presence of more than 50% of central apneas or Cheyne-Stokes respiration 6. Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases 7. Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions 8. Any medical, social or geographical factor that may endanger the patient's compliance 9-Having a profession of high risk (professional driver).
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What it tests

  • CPAP treatment
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Where

1 site
Hospital Arnau de Vilanova-Santa Maria
Lleida, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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