NCT03869125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

March 4, 2019

Last Update Submit

August 22, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

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

    1 day

Study Arms (1)

Obstructive sleep apnoea group

Blood pressure measurement

Diagnostic Test: Blood pressure measurement

Interventions

Blood pressure measurementDIAGNOSTIC_TEST

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

Obstructive sleep apnoea group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with suspected obstructive sleep apnoea syndrome

You may qualify if:

  • Obstructive sleep apnoea syndrome

You may not qualify if:

  • Non- compliance of patients with blood pressure monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • Milan Sova, MD.Ph.D.

    University Hospital Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Sleep Laboratory, Department of Respiratory Medicine

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

March 22, 2019

Primary Completion

August 22, 2019

Study Completion

August 22, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

CZ(1)