Sleep Apnea Clinical Trial
Official title:
The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.
The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has
developed a battery-powered implantable device that treats central sleep apnea. The device
is used with a lead that delivers the stimulation therapy which causes the patient to
breathe with a regular rhythm and an optional lead that senses breathing. This combination
is called the remedē® system.
The aim of this study is
1. to collect data in order to get a better understanding of the characteristics and/or
symptoms related to central sleep apnea
2. to collect safety information of all patients diagnosed with central sleep apnea
3. to obtain additional short and lang term information on the safety and performance of
the remedē® system, including an evaluation if there's an impact on the quality of life
of patients treated with the the remedē® system in daily practice.
The information obtained from this study may provide better insight on the symptoms related
to central sleep apnea, risk factors related to central sleep apnea therapy and use of the
remedē® system which may help to treat other patients with potential sleep disordered
breathing more appropriately.
Approximately 300 patients (to be) implanted with the remedē® system will participate in
this study at approximately 40 sites in Europe. For this purpose the investigators aim to
screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed
with central sleep apnea, but not receiving the device will be followed through phone calls
for 2 years.
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