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Treatment of central sleep apnoea and Cheyne Stokes respiration in patients with heart failure: nasal high-flow oxygen therapy?

Treatment of central sleep apnoea and Cheyne Stokes respiration in patients with heart failure: nasal high-flow oxygen therapy? - Nasal high flow in heart failure patients with CSAS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47575
Enrollment
10
Registered
2018-07-09
Start date
2017-08-08
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central sleep apnoea

Interventions

High Flow Therapy which is the application of humidified heated high-flow air, with or without the mixture with additional oxygen, through a nasal catheter. This therapy combines the positive effect
Central Sleep Apnea
Heart failure

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)