Masked Hypertension in Patients With Obstructive Sleep Apnoea

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT03869125
• Lead Sponsor: University Hospital Olomouc

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Study Start: 2019-03-22
• Status Verified: 2019-08
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Obstructive sleep apnoea syndrome

Exclusion Criteria

• Non- compliance of patients with blood pressure monitoring

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in masked hypertension prevalence between definition I and definition II	1 day	Masked hypertension- definition I- office blood pressure measurement \< 140/90 mmHg and daytime ambulatory blood pressure measurement \> 135/85 mmHg; Masked hypertension- definition II- automated office blood pressure measurement \< 140/90 and daytime ambulatory blood pressure measurement \> 135/85 mmHg

Trial Locations

Locations (1)

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia