Sleep Apnea SyndromesSRBD-CardioNCT02693925
Sleep-related Breathing Disorders in Cardiological Outpatients
An observational study of Sleep Apnea Syndromes, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 16 Dec 2014to 28 Sep 2018
- 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 cardiologic diseases who have a routine outpatient follow-up visit in the heart center of the University Clinic Cologne or are at the end of a cardivascular-related hospital stay in stable (recompensated) state.
Who may be able to join
- Age ≥18 years
- Present chronic cardiovascular disease (incl. but not limited to: ischemic heart disease, arterial hypertension, heart failure, atrial fibrillation)
- Current clinically stable state (incl. patients after a cardiovascular-related, emergency hospital admission and subsequent recompensation towards the end of their hospital stay
Who cannot join
- Age <18 years
- Acute life-threatening disease (incl. but not limited to:instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association (NYHA) stage IV, myocardial infarction, exacerbated chronic obstructive pulmonary disease (COPD), Malignant disease requiring treatment)
- Pregnancy and/or lactation
- Any medical, psychological or other condition impairing the patient's ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Cologne, Heart Center
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: Sleep-related Breathing Disorders in Cardiological Outpatients From a German University Clinic - Prevalence, Classification, Diagnostic Accuracy
The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy.
Furthermore, the practicability of the underlying diagnostic process in clinical application is assessed as well as the sensitivity and specificity of polygraphy as compared to the reference standard of polysomnography. Another aim is to determine the individual cardiovascular risk profile by pulse wave analysis and risk classification according to European Society of Hypertension (ESH) and European Society of Cardiology (ESC), "ESH/ESC risk".
- Conditions
- Sleep Apnea Syndromes
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep-related breathing disorders
Prevalence of sleep-related breathing disorders as measured by ambulatory polygraphy and defined as an respiratory disturbance index of >=15/h
Measured: Once within two days of inclusion
Secondary outcomes (5)
Number of patients included
Total number of patients included in the study after overall study conclusion
Measured: through study completion, an average of 21 months
Number of patients with actually performed polygraphy
Total number of patients in whom ambulatory polygraphy was actually performed, after overall study conclusion
Measured: through study completion, an average of 21 months
Number of patients with assessable polygraphy
Total number of patients in whom ambulatory polygraphy was assessable, after overall study conclusion
Measured: through study completion, an average of 21 months
Number of patients with actually performed polysomnography
Total number of patients in whom stationary polysomnography was actually performed, after overall study conclusion
Measured: through study completion, an average of 21 months
Number of patients with assessable polysomnography
Total number of patients in whom stationary polysomnography was assessable, after overall study conclusion
Measured: through study completion, an average of 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start16 Dec 2014
- Primary completion28 Sep 2016
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- University Clinic Cologne
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693925
- Sponsor's protocol ID
- WI_SBASKardio_14-322
- Acronym
- SRBD-Cardio
- Status last verified
- Oct 2018
- First submitted
- 17 Feb 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-related Breathing Disorders in Cardiological Outpatients From a German University Clinic - Prevalence, Classification, Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT02693925
- Acronym / sponsor ID
- SRBD-Cardio / WI_SBASKardio_14-322
- Conditions
- Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- University Clinic Cologne
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 29 Feb 2016 (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.
The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy.
Furthermore, the practicability of the underlying diagnostic process in clinical application is assessed as well as the sensitivity and specificity of polygraphy as compared to the reference standard of polysomnography. Another aim is to determine the individual cardiovascular risk profile by pulse wave analysis and risk classification according to European Society of Hypertension (ESH) and European Society of Cardiology (ESC), "ESH/ESC risk".
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiologic diseases who have a routine outpatient follow-up visit in the heart center of the University Clinic Cologne or are at the end of a cardivascular-related hospital stay in stable (recompensated) state.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Present chronic cardiovascular disease (incl. but not limited to: ischemic heart disease, arterial hypertension, heart failure, atrial fibrillation)
- Current clinically stable state (incl. patients after a cardiovascular-related, emergency hospital admission and subsequent recompensation towards the end of their hospital stay
Key exclusion criteria (4 listed)
- Age <18 years
- Acute life-threatening disease (incl. but not limited to:instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association (NYHA) stage IV, myocardial infarction, exacerbated chronic obstructive pulmonary disease (COPD), Malignant disease requiring treatment)
- Pregnancy and/or lactation
- Any medical, psychological or other condition impairing the patient's ability to provide informed consent
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
Prevalence of sleep-related breathing disorders
Time frame: Once within two days of inclusion
Prevalence of sleep-related breathing disorders as measured by ambulatory polygraphy and defined as an respiratory disturbance index of >=15/h
5 secondary outcomes
Number of patients included
Time frame: through study completion, an average of 21 months
Number of patients with actually performed polygraphy
Time frame: through study completion, an average of 21 months
Number of patients with assessable polygraphy
Time frame: through study completion, an average of 21 months
Number of patients with actually performed polysomnography
Time frame: through study completion, an average of 21 months
Number of patients with assessable polysomnography
Time frame: through study completion, an average of 21 months
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 29 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Winfried J Randerath, Prof. Dr. principal investigator
Wissenschaftliches Institut Bethanien e.V
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 Sleep Apnea Syndromes, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
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 4 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 29 Oct 2018. 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 Germany. 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?
Prevalence of sleep-related breathing disorders (time frame: Once within two days of inclusion). 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 29 Oct 2018.