Central Sleep Apnea, Cheyne-Stokes Respiration
Conditions
Keywords
High flow oxygen therapy
Brief summary
To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA). This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.
Detailed description
Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)\< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) \> 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded. Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively. Main study parameters/endpoints: 1. To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT. 2. To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT . 3. Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.
Interventions
nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective one armed uncontrolled intervention pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Moderate to severe CSA/CSR (AHI\>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas 2. Heart failure with reduced ejection fraction, defined as a LVEF \< 45% of predicted
Exclusion criteria
1. Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities) 2. At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of apnea/hypopnea index | Baseline, 4 weeks | the change/reduction in AHI after 4 weeks of treatment with nHFT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work of breathing | Baseline titration night | Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters |
| Drive to breath | Baseline titration night, 4 weeks | Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles |
| Sleep latency | Baseline, 4 weeks | Assessed as the the length of time that it takes to accomplish the transition from full wakefulness to sleep, measured by means of electro-encephalogram (ECG) as part of the polysomnography |
| Cardiac functioning | Baseline, 4 weeks | Left ventricular injection fraction (LVEF), |
| Improvement physical condition | Baseline, 4 weeks | Exercise tolerance assessed with the 6-minute walking test |
| Sleep efficiency | Baseline, 4 weeks | The percentage of total time in bed actually spent in sleep, assessed with polysomnography |
| Total rapid-eye movement (REM) stage sleep cycles recorded | Baseline, 4 weeks | Assessed with polysomnography |
| Heart rate variability | Baseline, 4 weeks | Heart rate variability will be assessed by 24-uur ECG recordings |
| N-terminal natriuretic peptide (NTproBNP) | Baseline, 4 weeks | Assessed in venous blood |
| change in oxygen desaturation index (ODI) during sleep while on nHFT | Baseline, 4 weeks | measured after 4 weeks of home nHFT treatment, as compared to the baseline ODI during spontaneous nocturnal breathing. |
Countries
Netherlands
Outcome results
None listed