RecruitingNot ApplicableNCT03948373

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)


Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Enrollment

64 participants

Start Date

May 7, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CPAP treatment for people with normotensive and sleep apnea, obstructive. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECPAP 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

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NCT03948373


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