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CompletedNCT03869125Updated Aug 26, 2019

Masked Hypertension in Patients With Obstructive Sleep Apnoea

An observational study in Obstructive Sleep Apnea, sponsored by University Hospital Olomouc. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-26.

Sponsored by University Hospital Olomouc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 65 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University Hospital Olomouc is the lead sponsor of 40 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with suspected obstructive sleep apnoea syndrome

Inclusion criteria

  • Obstructive sleep apnoea syndrome

Exclusion criteria

Exclusion Criteria:

  • Non- compliance of patients with blood pressure monitoring
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • Obstructive sleep apnoea group

    Blood pressure measurement

    Diagnostic Test: Blood pressure measurement

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

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What researchers measure

Primary outcomes

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

    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

    Time frame: 1 day

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Study locations

1 site
  • University Hospital Olomouc
    Olomouc, 77900, Czechia
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03869125
Lead sponsor
University Hospital Olomouc
Responsible party
Milan Sova (Head of Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc) — Principal investigator
First posted
Mar 11, 2019
Start date
Mar 22, 2019
Primary completion
Aug 22, 2019
Completion
Aug 22, 2019
Last update
Aug 26, 2019

Study contacts

Milan Sova, MD.Ph.D.
principal investigator · University Hospital Olomouc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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