Normotensive OSA Patients With Nondipper Circadian Blood Pressure Pattern
Condition: Normotensive; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in
      normotensive patients with nondipper 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 after
      CPAP treatment.

      Methodology: Open-label, parallel, prospective, randomized and controlled trial including
      normotensive patients with nondipper circadian pattern diagnosed with severe SAHS without
      significant somnolence. 64 patients with nondipper 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.
    

Detailed description: 
      1. Recruitment: Normotensive subjects referred to the sleep unit of the Hospital Santa
           Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and nondipper
           circadian blood pattern confirmed by ABPM and who do not present significant somnolence
           (Epworth≤18) will be included in the study.

        2. Definition of the groups: Patients will be randomized to receive one of the following
           treatments:

             -  CPAP: Patients who will receive CPAP treatment. The CPAP titration will be carried
                out with an automatic or manual CPAP according to usual clinical practice.

             -  Conservative treatment: Patients who will receive conservative treatment based on
                hygienic-dietetic measures.

        3. Randomization: It will be carried out with an automated platform

        4. Duration of the treatment: All patients randomized to CPAP will begin the treatment as
           soon as possible after randomization, and will continue treatment until the study ends
           (3 months).

           Patients who interrupt treatment will be excluded from the study. ABPM and blood sample
           collection will be performed on all included patients at the beginning of the study and
           at 3 months under treatment (CPAP or conservative care).

        5. Follow-up: All patients will be evaluated at the beginning of the study (T0), at first
           month (T1) and at three months (T2), during the follow-up period.
    

Intervention name(s): CPAP treatment
Intervention type(s): Device
Intervention description(s): In this group of patients (CPAP group) will be prescribed CPAP treatment at optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment