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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03869125
Enrollment
65
Registered
2019-03-11
Start date
2019-03-22
Completion date
2019-08-22
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DIAGNOSTIC_TESTBlood pressure measurement

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

Sponsors

University Hospital Olomouc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Obstructive sleep apnoea syndrome

Exclusion criteria

* Non- compliance of patients with blood pressure monitoring

Design outcomes

Primary

MeasureTime frameDescription
The difference in masked hypertension prevalence between definition I and definition II1 dayMasked 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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026