Obstructive Sleep ApnoeaOSANCT01685736
Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnoea and Hypertension, run by University of Athens at 2 sites in Greece.
Trial summary
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnoea, Hypertension
- How many people
- 50 participants
- Where
- 2 sitesGreece
- Study dates
- Feb 2012to Jun 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred to a sleep clinic
Who may be able to join
- Age ≤ 65 years
- Suspected OSA
- Treated or untreated for hypertension
Who cannot join
- History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke)
- History of asthma or chronic obstructive pulmonary disease (FEV1/FVC <70%)
- History of diabetes mellitus, collagen diseases and sarcoidosis
- Serum creatinine >1.6 mg/dl, proteinuria
- Previous treatment with CPAP
- Pregnancy or menstruation during the study
- Treatment with steroids, lithium or any other drugs affecting BP
- Change in antihypertensive treatment(if any) in the last 8 weeks before study entry
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
First University Department of Respiratory Medicine, Sotiria Hospital
Athens, 11527
Manos Alchanatis, Assoc. Prof. Respir. Medicine, +302107763685
Manos Alchanatis, Assoc. Prof. Respir. Medicine
- Recruiting
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, 11527
George S Stergiou, MD, +302107763117, gstergi@med.uoa.gr
George S Stergiou, MD
About this study
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).
- Conditions
- Obstructive Sleep Apnoea, Hypertension
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685736
- Sponsor's protocol ID
- OSA
- Acronym
- OSA
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01685736
- Acronym / sponsor ID
- OSA / OSA
- Conditions
- Obstructive Sleep Apnoea, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 14 Sep 2012 (estimated)
- 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.
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to a sleep clinic
Key inclusion criteria (3 listed)
- Age ≤ 65 years
- Suspected OSA
- Treated or untreated for hypertension
Key exclusion criteria (8 listed)
- History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke)
- History of asthma or chronic obstructive pulmonary disease (FEV1/FVC <70%)
- History of diabetes mellitus, collagen diseases and sarcoidosis
- Serum creatinine >1.6 mg/dl, proteinuria
- Previous treatment with CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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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.
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, Greece
2 sites 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 Apnoea and Hypertension, run by University of Athens at 2 sites in Greece.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 14 Sep 2012.