RECRUITINGINTERVENTIONAL

Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)

About This Trial

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 collection will be performed at the beginning of the study and at 3 months.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DEVICE

CPAP treatment

In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.

Locations (1)

Hospital Arnau de Vilanova-Santa Maria

Lleida, Spain