Masked Hypertensive Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Masked Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Masked Hypertension
Study type: Interventional

Summary: 
      The general objective is to evaluate the effect of continuous positive airway pressure (CPAP)
      treatment in patients with masked hypertension.

      The secondary objectives are: i) To evaluate the prevalence of different circadian patterns
      of BP in ambulatory blood pressure monitoring (ABPM) (dipper / non-dipper); ii) To assess in
      these patients the relationship between compliance with CPAP treatment and the response to
      nocturnal BP; iii) To identify variables of the ABPM, and biomarkers that are related to the
      unfavourable pattern of nocturnal BP response in these patients treated with CPAP; iv) To
      evaluate the change in the profile of biomarkers with the treatment.

      Methodology: Open, parallel, prospective, randomized and controlled study in which an ABPM
      will be performed in individuals with masked hypertension referred to the sleep unit and
      diagnosed of OSA (AHI≥ 30) without sleepiness (Epworth≤18).

      A total of 64 subjects with OSA and masked hypertension will be recruited. It will be
      collected blood for the determination of biomarkers. Subsequently, they will be randomized to
      receive treatment with CPAP (32) or conservative treatment (32). After 3 months of
      initiation, ABPM and biological determinations will be repeated.
    

Detailed description: 
      Recruitment: It will be recruited subjects with masked hypertension. For that, normotensive
      subjects (Blood pressure (BP)<140/90mmHg in the office) referred to the sleep unit of the
      Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and
      who do not present significant somnolence (Epworth≤18) will be proposed to participate in the
      study. Then, it will be performed an ABPM during-24 hours, and those subjects with an
      abnormal ABPM results and normal BP in the office will be included, are those subjects called
      masked hypertensive.

      Definition of the groups: Patients will be randomized to receive one of the following
      treatments:

        1. 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.

        2. Conservative treatment: Patients who will receive conservative treatment based on
           hygienic-dietetic measures.

      Randomization: It will be carried out with an automated platform

      Duration of the treatment: All patients randomized to CPAP will begin 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).

      Follow-up: All patients will be evaluated at the beginning of the study, at first month and
      at three months 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 an 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
Intervention model description: This is an open-label, parallel, prospective, randomized and controlled trial.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Masked hypertension