NCT02577445

The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice

The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea
• Central Sleep Disordered Breathing

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-10-16
• Last updated: 2017-04-06
• Results posted: 2017-04-06

Locations

10 sites across 2 countries: Germany, Spain