central sleep apnoea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Moderate to severe central sleep apnoea (CSA)/Cheyne Stokes respiration (apnoea/hypopnoea index>15), in which CSA is defined when at least 50% of the apnoea*s are central apnoea*s • Heart failure diagnosed by cardiologist
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities) • At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as CPAP, oxygen, BiPAP or acetazolamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to investigate whether patients with CHF and CSA would benefit from nHFT with and without oxygen in terms of an improved AHI during sleep while on nHFT, measured after 4 weeks of home nHFT treatment, as compared to the baseline AHI during spontaneous nocturnal breathing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: • 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. • sleep quality, assessed by polysomnography, after 4 weeks of home nHFT treatment compared to baseline. • exercise tolerance, measured with the 6-minute walking test, after 4 weeks of home nHFT treatment compared to baseline. • Symptoms of sleepiness, assessed by validated questionnaires, after 4 weeks of home nHFT treatment compared to baseline. • Cardiac functioning; LVEF, heart rate variability and N-terminal natriuretic peptide (NTproBNP), after 4 weeks of home nHFT treatment compared to baseline. • Compliance with the nHFT Furthermore, with a titration night at baseline, we will investigate mechanisms of action and optimal settings of nHFT in this group of patients. We will investigate effects of different flow rates and oxygen percentage on the pressures in the circuit and in the pharynx. As this pressure is expected to have effects on the breathing drive and the work of breathing, we will also investigate these parameters with the use of surface electromyography (EMG) and transdiaphragmatic pressure measurements. * | — |
Countries
The Netherlands