Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSociedad Española de Neumología y Cirugía Torácica

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.

Eligibility criteria

Qualifiers

Men and women over 18 years of age

Referred to the sleep unit for suspected OSA

Being normotensive and presenting an AHI ≥ 30 in the sleep study

Signature of the informed consent.

Disqualifiers

Previous CPAP treatment

Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18

Psychophysical inability to complete questionnaires

Previous diagnosis or suspicion of another sleep disorder

Trial design

Treatments tested in this trial

  • CPAP treatment

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sociedad Española de Neumología y Cirugía Torácica

Lead sponsor

Societat Catalana de Pneumologia

Collaborator