Sleep Disordered Breathing Clinical Trial
Official title:
Adaptive Servo Ventilation (ASV) in the Management of Acute Decompensated Heart Failure (ADHF)
Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep
disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and
have important prognostic implications. SDB is however, treatable with the use of non
invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The
aim of the study is to observe and investigate the potential role of ASV in the management of
heart failure.
Patients that agree to participate in this study will be requested to use an ASV ventilator
device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is
approximately the size of a large shoe box, which can be placed at the side of the bed, with
tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows
positive air pressure as determined by the device itself as it constantly monitors the
patients breathing throughout the night. During this study, the patients breathing patterns
will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a
SleepMinder will sit on the patients bedside locker as another form of monitoring of their
sleep patterns. Study staff will monitor the patient and give them frequent support, and they
will also be asked questions regarding their experiences with this equipment and any symptoms
they may have over this time. They will be followed up regarding this study at the same time
as their follow-up requirements for their heart failure. This study will be conducted in
total over 3 months.
Sleep disordered breathing (SDB) is common in patients with heart failure (HF) and is an
independent predictor of morbidity and mortality. Adaptive servo-ventilation (ASV) is
reported as the most effective treatment for SDB in HF and has been shown to improve cardiac
function in patients with HF coexistent with SDB. ASV may also be an effective therapeutic
option for patients with HF regardless of presence or severity of SDB.
The aim of the study is to investigate the potential role for ASV in improving the management
of ADHF in the acute hospital phase and reducing complications in the vulnerable post
discharge period. This is an observational study of forty patients admitted to hospital with
ADHF.
In this clinical investigation, the ApneaLinkTM Plus device will measure patient respiratory
nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep.
The research participant will be connected to the device during their inpatient
hospitalisation as soon as they are stabilised off oxygen. These recordings will aid the
diagnosis of SDB for further clinical investigation.
The S9 Autoset CS-A system will be evaluated to determine whether ASV has beneficial effects
on the cardiac function of patients with ADHF. During an in-patient run-in phase, the
patients tolerability to ASV therapy will be assessed and if tolerated well, the patient will
continue with this therapy following discharge for 45 days.
The SleepMinder sensor device will monitor the sleep and breathing patterns of the
participants as they sleep, and in doing so, sleep apnoeas will be detected. Each patient
will monitor their weight daily using a Precision Personal Health Scales for 90 days.
Finally, a questionnaire will be completed by the patient which allows them to self-report
their HF symptoms.
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