Masked Hypertensive Patients With Obstructive Sleep Apnea
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Masked Hypertension
- Obstructive Sleep Apnea
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an open-label, parallel, prospective, randomized and controlled trial.Masking: Single (Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
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 signific...
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: 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. 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.
Tracking Information
- NCT #
- NCT04251975
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ferran Barbé Illa, MD CIBERES, SEPAR