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Completed

NCT Number: NCT03869125

Masked Hypertension in Patients With Obstructive Sleep Apnoea

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructive sleep apnoea syndrome

Exclusion criteria

  • Non- compliance of patients with blood pressure monitoring

Treatment and study plan

Blood pressure measurement

Diagnostic Test

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

Primary outcomes

  1. The difference in masked hypertension prevalence between definition I and definition II

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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