Obstructive Sleep ApneaNCT03869125
Masked Hypertension in Patients With Obstructive Sleep Apnoea
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Blood pressure measurement
- How many people
- 65 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Mar 2019to 22 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected obstructive sleep apnoea syndrome
Who may be able to join
- Obstructive sleep apnoea syndrome
Who cannot join
- Non- compliance of patients with blood pressure monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) 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.
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Blood pressure measurement
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnoea group | Blood pressure measurement Receives: Diagnostic Test: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start22 Mar 2019
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milan Sova, University Hospital Olomouc
- Investigators
- Milan Sova, MD.Ph.D., Principal investigator, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869125
- Sponsor's protocol ID
- OSAS_MH
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) in Patients With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT03869125
- Acronym / sponsor ID
- OSAS_MH
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnoea group | – | Diagnostic Test: Blood pressure measurementBlood pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected obstructive sleep apnoea syndrome
Key inclusion criteria (1 listed)
- Obstructive sleep apnoea syndrome
Key exclusion criteria (1 listed)
- Non- compliance of patients with blood pressure monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurementBlood pressure monitoring using automated office blood pressure measurement (AOBPM), office blood pressure measurement (OBPM), and 24-hour ambulatory blood pressure monitoring | Diagnostic test | Obstructive sleep apnoea group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Sova, MD.Ph.D. principal investigator
University Hospital Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in masked hypertension prevalence between definition I and definition II (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.