Clinical Trials Directory

Trials / Completed

CompletedNCT03869125

Masked Hypertension in Patients With Obstructive Sleep Apnoea

Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) in Patients With Obstructive Sleep Apnoea

Status
Completed
Phase
Study type
Observational
Enrollment
65 (actual)
Sponsor
University Hospital Olomouc · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Assessment of the possible difference in masked hypertension prevalence when it is evaluated by automated office blood pressure measurement (AOBPM) instead of office blood pressure measurement (OBPM) in patients with obstructive sleep apnoea.

Detailed description

Rationale: Obstructive sleep apnoea is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50%+ blood oxygen desaturation \> 4%). It is considered to be an important risk factor for arterial hypertension. In these patients is highly prevalent nocturnal hypertension (NH) and also masked hypertension (MH). Ambulatory blood pressure monitoring (ABPM) is considered to be a gold standard for the diagnosis of NH and MH. Results of ABPM are compared with office blood pressure measurement which could be falsely elevated in some patients (white coat effect). For this reason, automatic office blood pressure measurement was developed. Nowadays some devices like BpTRU were developed. This was validated on some patient groups but robust data for patients with obstructive sleep apnoea are missing. Process: Patient with ronchopathy and suspected obstructive sleep apnoea undergo automated office blood pressure monitoring followed by office blood pressure monitoring at the Department of Exercise Medicine and Cardiovascular Rehabilitation. After education, ambulatory blood pressure monitor will be provided to patients for the following 24 hours. In the same night, respiratory polygraphy will be performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc. All data will be statistically evaluated after completion of the target number of subjects. Patients without obstructive sleep apnoea (apnoea-hypopnoea index \< 5) will not be included in statistical evaluations.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood pressure measurementBlood pressure monitoring using automated office blood pressure measurement (AOBPM), office blood pressure measurement (OBPM), and 24-hour ambulatory blood pressure monitoring

Timeline

Start date
2019-03-22
Primary completion
2019-08-22
Completion
2019-08-22
First posted
2019-03-11
Last updated
2019-08-26

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT03869125. Inclusion in this directory is not an endorsement.