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Masked Hypertension in Patients With Obstructive Sleep Apnoea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869125
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Milan Sova, University Hospital Olomouc

Study Description
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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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diagnostic Test: Blood pressure measurement

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 Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) in Patients With Obstructive Sleep Apnoea
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort Intervention/treatment
Obstructive sleep apnoea group
Blood pressure measurement
 Diagnostic Test: Blood pressure measurement
Blood pressure monitoring using automated office blood pressure measurement (AOBPM), office blood pressure measurement (OBPM), and 24-hour ambulatory blood pressure monitoring


Outcome Measures
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Primary Outcome Measures :
  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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with suspected obstructive sleep apnoea syndrome
Criteria

Inclusion Criteria:

  • Obstructive sleep apnoea syndrome

Exclusion Criteria:

  • Non- compliance of patients with blood pressure monitoring
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869125


Locations
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Czechia
University Hospital Olomouc
Olomouc, Czechia, 77900
Sponsors and Collaborators
University Hospital Olomouc
Investigators
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Principal Investigator: Milan Sova, MD.Ph.D. University Hospital Olomouc
More Information
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Responsible Party: Milan Sova, Head of Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc
ClinicalTrials.gov Identifier: NCT03869125    
Other Study ID Numbers: OSAS_MH
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension
Masked Hypertension
Vascular Diseases
Cardiovascular Diseases
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases