Sleep Disordered BreathingClipSDBNCT03813511
Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure
An observational study of Sleep Disordered Breathing and Valvular Regurgitation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Valvular Regurgitation
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 31 Jul 2022
- How long will I take part?
- 3 Months
- 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: Stationäre patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique
Who may be able to join
- Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique
Who cannot join
- Patients with more then one valvular disease which requires Treatment
- Patients with complex congenital heart disease
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, 32545
About this study
Official title: Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure
In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.
Read the detailed description
The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique.
Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires.
The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study.
The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.
- Conditions
- Sleep Disordered Breathing, Valvular Regurgitation
- Keywords
- Minimally invasive surgery, Clip procedure
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation
Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period
Measured: 3 month
Influence of the minimal invasive Clip technique on apnea-hypopnea index
Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on apnea index
Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on the oxygen desaturation index
Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on T90
Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on sleep cycle length
Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on ventilation length during sleep
Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography
Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography
Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography
Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Measured: 3 month
Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography
Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Measured: 3 month
Secondary outcomes (9)
Post-interventional changes in daytime sleepiness with and without sleep disordered breathing
Post-interventional changes in daytime sleepiness with and without sleep disordered breathing measured by the Epworth Sleepinss Scale (ESS) (From 0 to 24 point-scale; A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates severe daytime sleepiness)
Measured: 3 month
Post-interventional survey of patient health with and without sleep disordered breathing
Post-interventional survey of patient health with and without sleep disordered breathing measured by the Short Form (36) Health Survey (SF-36).
SF-36 consists of eight scaled score (Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). Total range from 0 to 100 points (from worst to best)
Measured: 3 month
Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure
Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) that hat quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Total range is from 0 to 100 points. 0 denotes the worst and 100 the best possible health status
Measured: 3 month
Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing
Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing using the Minnesota Living with Heart Failure Questionnaire. It provides a total score range 0-105, from best to worst
Measured: 3 month
Post-interventional assessment of the sleep quality with and without sleep disordered breathing
Post-interventional assessment of the sleep quality with and without sleep disordered breathing using the Pittsburgh Sleep Quality Index (PSQI) (From 0 (worst) to 21 (best))
Measured: 3 month
Post-interventional changes in generic health status. with and without sleep disordered breathing
Post-interventional changes in generic health status. with and without sleep disordered breathing using the EQ-5D questionnaire (grade ranging from 0, the worst possible health status, to 100 ,the best possible health status
Measured: 3 month
Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing
Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram
Measured: 3 month
Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing
Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the six minutes walk test (in meters)
Measured: 3 month
Post-interventional changes on cognitive functions with and without sleep disordered breathing
Post-interventional changes on cognitive functions with and without sleep disordered breathing using the Montreal Cognitive Assessment Test (MOCA) (From 0 (worst) to 30 (best) point-scale)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Dec 2018
- Primary completion14 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Muhammed Gercek, MD, Principal investigator, Heart and Diabetes Center North Rhine-Westphalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813511
- Sponsor's protocol ID
- HDZ-KA_015_MG
- Acronym
- ClipSDB
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure
- ClinicalTrials.gov ID
- NCT03813511
- Acronym / sponsor ID
- ClipSDB / HDZ-KA_015_MG
- Conditions
- Sleep Disordered Breathing, Valvular Regurgitation
- Keywords
- Minimally invasive surgery, Clip procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Jan 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.
In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.
Detailed description
The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique.
Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires.
The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study.
The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stationäre patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique
Key inclusion criteria (1 listed)
- Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique
Key exclusion criteria (3 listed)
- Patients with more then one valvular disease which requires Treatment
- Patients with complex congenital heart disease
- Pregnant women
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
Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation
Time frame: 3 month
Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period
Influence of the minimal invasive Clip technique on apnea-hypopnea index
Time frame: 3 month
Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on apnea index
Time frame: 3 month
Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the oxygen desaturation index
Time frame: 3 month
Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on T90
Time frame: 3 month
Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on sleep cycle length
Time frame: 3 month
Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on ventilation length during sleep
Time frame: 3 month
Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography
Time frame: 3 month
Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography
Time frame: 3 month
Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography
Time frame: 3 month
Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique
Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography
Time frame: 3 month
Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique
9 secondary outcomes
Post-interventional changes in daytime sleepiness with and without sleep disordered breathing
Time frame: 3 month
Post-interventional survey of patient health with and without sleep disordered breathing
Time frame: 3 month
Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure
Time frame: 3 month
Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing
Time frame: 3 month
Post-interventional assessment of the sleep quality with and without sleep disordered breathing
Time frame: 3 month
Post-interventional changes in generic health status. with and without sleep disordered breathing
Time frame: 3 month
Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing
Time frame: 3 month
Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing
Time frame: 3 month
Post-interventional changes on cognitive functions with and without sleep disordered breathing
Time frame: 3 month
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 6 Mar 2023.
- 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.
Muhammed Gercek, MD principal investigator
Heart and Diabetes Center North Rhine-Westphalia
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 Disordered Breathing and Valvular Regurgitation, run by Heart and Diabetes Center North-Rhine Westfalia 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 1 inclusion and 3 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 6 Mar 2023. 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?
Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation (time frame: 3 month). The study lists 11 primary outcomes in all. 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 6 Mar 2023.