Obstructive Sleep ApnoeaNCT03092388
Leg Fluid Shift in Patients With Chronic Heart Failure and Obstructive or Central Sleep Apnea
A study testing Multi Frequency Bioimpedance Analysis (mfBIA), Polysomnography/Polygraphy (PSG/PG) and Capillary Blood Gas Analysis (CBGA) in people with Obstructive Sleep Apnoea and Central Sleep Apnoea, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea (CSA). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Obstructive Sleep Apnoea, Central Sleep Apnoea, Cheyne Stokes Respiration
- What is being tested?
- Multi Frequency Bioimpedance Analysis (mfBIA), Polysomnography/Polygraphy (PSG/PG) and Capillary Blood Gas Analysis (CBGA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Heart Failure
- reduced left ventricular ejection fraction (LVEF) ≤ 45%
- NYHA I - IV
Who cannot join
- current existing sleep apnoea breathing therapy
- significant chronic obstructive pulmonary disease (COPD) Tiffenau-Index: <70%
- respiratory insufficiency with need for a long time oxygen therapy
- hypercapnic state in rest at day time
- acute myocardial infarction at moment of study
- instable angina pectoris at moment of study
Show all 10Show fewer
- cardiac surgery in last twelve weeks
- stroke or TIA in last twelve weeks
- implantable cardioverter-defibrillator, if there is no security clearance of the fabricator
- chronic kidney disease > Stage III
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart - and Diabetes CenteHerz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
Bad Oeynhausen, North - Rhine Westfalia, 32545
About this study
Official title: Evaluation Eines Leg Fluid Shift Und Erörterung Der hämodynamischen Und Respiratorischen Auswirkungen Auf Patienten Mit Chronischer Herzinsuffizienz Und Obstruktiver Oder Zentraler Schlafapnoe
This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea (CSA).
Read the detailed description
Chronic heart failure (CHF) is a common disease in general western population with high levels of morbidity and mortality. Prospective risk factors need to be identified and investigated. The prevalence for sleep disordered breathing (SDB) in patients with CHF is higher compared to general population. Especially the occurence of CSA with its special breathing pattern of Cheyne-Stokes-Respiration (CSR) is frequent in CHF patients.The pathophysiology and relation inbetween sleep apnea (SA) and CHF isn´t completely identified yet. Multiple theories with different strategies try to explain the pathophysics and development of SA. Following one of these theories, patients with CHF often develop edema in lower body compartments. The idea is a possible influence of retrograde nocturnal LFS from lower body to upper body compartments which could induce pulmonal congestion. Therefore, an increased pulmonary capillary wedge pressure (PCWP) could irritate special pulmonal receptors resulting in CSR with periods of hyperventilation, related hypocapnia and central apnea events. OSA could be induced by fluid accumulation in the upper airway by retrograde fluid shift.
Patients with known CHF receive fluid measurements by b multi frequency bioimpedance analysis (mfBIA) the evening before and the morning after sleep is recorded using polygraphy (PG) or polysomnography (PSG) in hospital. Sleep results are analyzed by physicians using current guidelines of the American Academy of Sleep Medicine (AASM).
Capillary blood gas (CBG) samples are taken before and after sleep to examine the relation of fluid shift and blood gas changes.
A subgroup of the study group undergo additional investigation. Hemodynamic effects (e.g. reduced cardiac output (CO)) as a cause of a potential fluid shift is measured during wakefulness by using a tilting table. Hemodynamically relevant parameters are recorded non-invasively.
- Being tested
- Multi Frequency Bioimpedance Analysis (mfBIA), Polysomnography/Polygraphy (PSG/PG), Capillary Blood Gas Analysis (CBGA), Tilting Table with Hemodynamic Monitoring
- Keywords
- Sleep-Disordered Breathing, Heart Failure, Leg Fluid Shift
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central, Cheyne-Stokes Respiration, Sleep Apnea Syndromes, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Frequency Bioimpedance Analysis (mfBIA)Diagnostic test
Also called Nutriguard M, Data Input, Darmstadt, Germany
Multi Frequency Bioimpedance Analysis (mfBIA) uses very small electric current at different frequencies (5, 50, 100 kHz) to measure the resistance and reactance of the entire body and different segmental body compartiments. With a special software total body fluid can be calculated. By analyzing raw data at different frequencies a detailed view on body and segments fluid distribution is possible.
Polysomnography/Polygraphy (PSG/PG)Diagnostic test
Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.
Capillary Blood Gas Analysis (CBGA)Diagnostic test
CBGA is a less invasive method to gain arterial blood like gas samples without the punctation of an artery. After inducing a good capillary perfusion, capillary blood is taken by a small punctation of the tip of one ear. The sample is automatically analysed in a blood gas analyzer.
Tilting Table with Hemodynamic MonitoringDiagnostic test
Also called Task Force Monitor, CNsystems, Vienna, Austria
A tilting table offers the opportunity to turn a study subject automatically from vertical into horizontal position and back. By using non-invasive monitoring technique, hemodynamic parameters are recorded permanently.
| Study group | Role | What they receive |
|---|---|---|
| Study Group Basic | Experimental | Patients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA. Receives: Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA); Diagnostic Test: Polysomnography/Polygraphy (PSG/PG); Diagnostic Test: Capillary Blood Gas Analysis (CBGA) |
| Study Group Extended | Experimental | Patients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA.
Additionally, during daytime a special test with random parts of the study group basic is performed:
A tilting table with hemodynamic monitoring is used to induce an artificial LFS by moving patients from vertical into horizontal position. Bodyfluid changes are monitored by mfBIA during this procedure. Receives: Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA); Diagnostic Test: Polysomnography/Polygraphy (PSG/PG); Diagnostic Test: Capillary Blood Gas Analysis (CBGA); Diagnostic Test: Tilting Table with Hemodynamic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
∆ Leg Fluid Shift (LFS)
[%] Difference between the raw data of leg fluid volume before and after sleep.
Measured: one night
Secondary outcomes (14)
Apnea-Hypopnea-Index (AHI)
[/h], definition after current AASM guideline
Measured: one night
Cheyne-Stokes-Respiration
[min] + [(%) of Total Sleep Time (TST)]
Measured: one night
Oxygen-Desaturation-Index (ODI)
[/h], definition after current AASM guideline
Measured: one night
Time Oxygen Saturation < 90% (TSpO2<90%)
[min] + [% (of TST)]
Measured: one night
Oxygen Saturation (SpO2)
Measured: one night
Sleep Efficiency
Measured: one night
Longest Apnea time
[min]
Measured: one night
Longest Hypopnea time
[min]
Measured: one night
∆ partial pressure in capillary blood of carbon dioxide (pcCO2)
[mmHG] Difference of pcCO2 before and after sleep
Measured: one night
∆ partial pressure in capillary blood of oxygen (pcO2)
[mmHG] Difference of pcO2 before and after sleep
Measured: one night
∆ Resistance
[Ohm]
Measured: one night
∆ Reactance
[Ohm]
Measured: one night
∆ Total Body Water (TBW)
[l]
Measured: one night
Blood Pressure (systolic, diastolic, mean)
[mmHg]
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Thomas Bitter, MD, Study director, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, GermanySchindhelm Florian, Principal investigator, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092388
- Sponsor's protocol ID
- HDZNRW-KA_004_TB
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 4 Apr 2017
- 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 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Eines Leg Fluid Shift Und Erörterung Der hämodynamischen Und Respiratorischen Auswirkungen Auf Patienten Mit Chronischer Herzinsuffizienz Und Obstruktiver Oder Zentraler Schlafapnoe
- ClinicalTrials.gov ID
- NCT03092388
- Acronym / sponsor ID
- HDZNRW-KA_004_TB
- Keywords
- Sleep-Disordered Breathing, Heart Failure, Leg Fluid Shift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Mar 2017 (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.
This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea (CSA).
Detailed description
Chronic heart failure (CHF) is a common disease in general western population with high levels of morbidity and mortality. Prospective risk factors need to be identified and investigated. The prevalence for sleep disordered breathing (SDB) in patients with CHF is higher compared to general population. Especially the occurence of CSA with its special breathing pattern of Cheyne-Stokes-Respiration (CSR) is frequent in CHF patients.The pathophysiology and relation inbetween sleep apnea (SA) and CHF isn´t completely identified yet. Multiple theories with different strategies try to explain the pathophysics and development of SA. Following one of these theories, patients with CHF often develop edema in lower body compartments. The idea is a possible influence of retrograde nocturnal LFS from lower body to upper body compartments which could induce pulmonal congestion. Therefore, an increased pulmonary capillary wedge pressure (PCWP) could irritate special pulmonal receptors resulting in CSR with periods of hyperventilation, related hypocapnia and central apnea events. OSA could be induced by fluid accumulation in the upper airway by retrograde fluid shift.
Patients with known CHF receive fluid measurements by b multi frequency bioimpedance analysis (mfBIA) the evening before and the morning after sleep is recorded using polygraphy (PG) or polysomnography (PSG) in hospital. Sleep results are analyzed by physicians using current guidelines of the American Academy of Sleep Medicine (AASM).
Capillary blood gas (CBG) samples are taken before and after sleep to examine the relation of fluid shift and blood gas changes.
A subgroup of the study group undergo additional investigation. Hemodynamic effects (e.g. reduced cardiac output (CO)) as a cause of a potential fluid shift is measured during wakefulness by using a tilting table. Hemodynamically relevant parameters are recorded non-invasively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group Basic | Experimental | Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA), Diagnostic Test: Polysomnography/Polygraphy (PSG/PG), Diagnostic Test: Capillary Blood Gas Analysis (CBGA)Patients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA. |
| Study Group Extended | Experimental | Diagnostic Test: Multi Frequency Bioimpedance Analysis (mfBIA), Diagnostic Test: Polysomnography/Polygraphy (PSG/PG), Diagnostic Test: Capillary Blood Gas Analysis (CBGA), Diagnostic Test: Tilting Table with Hemodynamic MonitoringPatients receive Multi Frequency Bioimpedance Analysis (mfBIA) before and after sleep recording by Polysomnography/Polygraphy (PSG/PG) in hospital. Capillary Blood Gas Analysis (CBGA) is performed before and after sleep according to mfBIA. Additionally, during daytime a special test with random parts of the study group basic is performed: A tilting table with hemodynamic monitoring is used to induce an artificial LFS by moving patients from vertical into horizontal position. Bodyfluid changes are monitored by mfBIA during this procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Heart Failure
- reduced left ventricular ejection fraction (LVEF) ≤ 45%
- NYHA I - IV
Key exclusion criteria (10 listed)
- current existing sleep apnoea breathing therapy
- significant chronic obstructive pulmonary disease (COPD) Tiffenau-Index: <70%
- respiratory insufficiency with need for a long time oxygen therapy
- hypercapnic state in rest at day time
- acute myocardial infarction at moment of study
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 |
|---|---|---|
| Multi Frequency Bioimpedance Analysis (mfBIA)Also: Nutriguard M, Data Input, Darmstadt, GermanyMulti Frequency Bioimpedance Analysis (mfBIA) uses very small electric current at different frequencies (5, 50, 100 kHz) to measure the resistance and reactance of the entire body and different segmental body compartiments. With a special software total body fluid can be calculated. By analyzing raw data at different frequencies a detailed view on body and segments fluid distribution is possible. | Diagnostic test | Study Group Basic, Study Group Extended |
| Polysomnography/Polygraphy (PSG/PG)Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines. | Diagnostic test | Study Group Basic, Study Group Extended |
| Capillary Blood Gas Analysis (CBGA)CBGA is a less invasive method to gain arterial blood like gas samples without the punctation of an artery. After inducing a good capillary perfusion, capillary blood is taken by a small punctation of the tip of one ear. The sample is automatically analysed in a blood gas analyzer. | Diagnostic test | Study Group Basic, Study Group Extended |
| Tilting Table with Hemodynamic MonitoringAlso: Task Force Monitor, CNsystems, Vienna, AustriaA tilting table offers the opportunity to turn a study subject automatically from vertical into horizontal position and back. By using non-invasive monitoring technique, hemodynamic parameters are recorded permanently. | Diagnostic test | Study Group Extended |
Primary outcome
∆ Leg Fluid Shift (LFS)
Time frame: one night
[%] Difference between the raw data of leg fluid volume before and after sleep.
14 secondary outcomes
Apnea-Hypopnea-Index (AHI)
Time frame: one night
Cheyne-Stokes-Respiration
Time frame: one night
Oxygen-Desaturation-Index (ODI)
Time frame: one night
Time Oxygen Saturation < 90% (TSpO2<90%)
Time frame: one night
Oxygen Saturation (SpO2)
Time frame: one night
Sleep Efficiency
Time frame: one night
Longest Apnea time
Time frame: one night
Longest Hypopnea time
Time frame: one night
∆ partial pressure in capillary blood of carbon dioxide (pcCO2)
Time frame: one night
∆ partial pressure in capillary blood of oxygen (pcO2)
Time frame: one night
∆ Resistance
Time frame: one night
∆ Reactance
Time frame: one night
∆ Total Body Water (TBW)
Time frame: one night
Blood Pressure (systolic, diastolic, mean)
Time frame: one night
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Thomas Bitter, MD study director
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Schindhelm Florian principal investigator
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi Frequency Bioimpedance Analysis (mfBIA), Polysomnography/Polygraphy (PSG/PG) and Capillary Blood Gas Analysis (CBGA) in people with Obstructive Sleep Apnoea and Central Sleep Apnoea, 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 3 inclusion and 10 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 4 Apr 2017. 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?
∆ Leg Fluid Shift (LFS) (time frame: one night). 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 4 Apr 2017.