Central Sleep Apnoea, Cheyne Stokes Respiration, Obstructive Sleep Apnoea
Conditions
Keywords
Sleep-Disordered Breathing, Heart Failure, Leg Fluid Shift
Brief 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).
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.
Interventions
DIAGNOSTIC_TESTMulti Frequency Bioimpedance Analysis (mfBIA)
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.
DIAGNOSTIC_TESTPolysomnography/Polygraphy (PSG/PG)
Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.
DIAGNOSTIC_TESTCapillary 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_TESTTilting Table with Hemodynamic Monitoring
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.
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Heart Failure * reduced left ventricular ejection fraction (LVEF) ≤ 45% * NYHA I - IV
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ∆ Leg Fluid Shift (LFS) | one night | \[%\] Difference between the raw data of leg fluid volume before and after sleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen-Desaturation-Index (ODI) | one night | \[/h\], definition after current AASM guideline |
| Oxygen Saturation (SpO2) | one night | — |
| Sleep Efficiency | one night | — |
| Longest Apnea time | one night | \[min\] |
| Longest Hypopnea time | one night | \[min\] |
| ∆ partial pressure in capillary blood of carbon dioxide (pcCO2) | one night | \[mmHG\] Difference of pcCO2 before and after sleep |
| ∆ partial pressure in capillary blood of oxygen (pcO2) | one night | \[mmHG\] Difference of pcO2 before and after sleep |
| ∆ Resistance | one night | \[Ohm\] |
| ∆ Reactance | one night | \[Ohm\] |
| ∆ Total Body Water (TBW) | one night | \[l\] |
| Blood Pressure (systolic, diastolic, mean) | one night | \[mmHg\] |
| Apnea-Hypopnea-Index (AHI) | one night | \[/h\], definition after current AASM guideline |
| Cheyne-Stokes-Respiration | one night | \[min\] + \[(%) of Total Sleep Time (TST)\] |
| Time Oxygen Saturation < 90% (TSpO2<90%) | one night | \[min\] + \[% (of TST)\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| ∆ pcO2 | one hour | \[mmHG\] Difference of pcO2 before and after sleep |
| Thoracic Fluid Content (TFC) | one hour | \[1/kOhm\] |
| ∆ Leg Fluid Shift | one hour. | \[%\] Difference between the raw data of leg fluid volume before and after tilting table. |
| ∆ Total Body Water | one hour | \[l\] |
| Oxygen Saturation | one hour | — |
| Blood Pressure (systolic, diastolic and mean) | one hour | \[mmHg\] |
| ∆ Resistance (legs, body) | one hour | \[Ohm\] electrical resistance |
| ∆ Reactance (legs, body) | one hour | \[Ohm\] capacitive resitance |
| Cardiac Index | one hour | \[(l/min)/m²\] Cardiac output from left ventricle related to body surface during tilting table |
| ∆ pcCO2 | one hour | \[mmHG\] Difference of pcCO2 before and after tilting table |
Countries
Germany
Outcome results
None listed