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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively
Department of Pulmonary diseases
Groningen, Netherlands
Reduction of apnea/hypopnea index
the change/reduction in AHI after 4 weeks of treatment with nHFT.
Time frame: Baseline, 4 weeks
Improvement physical condition
Exercise tolerance assessed with the 6-minute walking test
Time frame: Baseline, 4 weeks
Work of breathing
Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters
Time frame: Baseline titration night
Drive to breath
Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles
Time frame: Baseline titration night, 4 weeks
Sleep latency
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
Time frame: Baseline, 4 weeks
Cardiac functioning
Left ventricular injection fraction (LVEF),
Time frame: Baseline, 4 weeks
change in oxygen desaturation index (ODI) during sleep while on nHFT
measured after 4 weeks of home nHFT treatment, as compared to the baseline ODI during spontaneous nocturnal breathing.
Time frame: Baseline, 4 weeks
Sleep efficiency
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The percentage of total time in bed actually spent in sleep, assessed with polysomnography
Time frame: Baseline, 4 weeks
Total rapid-eye movement (REM) stage sleep cycles recorded
Assessed with polysomnography
Time frame: Baseline, 4 weeks
Heart rate variability
Heart rate variability will be assessed by 24-uur ECG recordings
Time frame: Baseline, 4 weeks
N-terminal natriuretic peptide (NTproBNP)
Assessed in venous blood
Time frame: Baseline, 4 weeks