Clinical trial NCT02577445: The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice
Official title: The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep Apnea
Central Sleep Disordered Breathing
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: Respicardia, Inc.
First posted: 2015-10-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with central sleep apnea

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All patients screened for sleep disordered breathing
* Age \> 18 years
* Signed Ethics Committee approved informed consent

Implant Inclusion criteria

* Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system

Implant Exclusion Criteria:

* Patients meeting the criteria as referred to in the latest version of the implant manual

Primary outcomes:
measure: Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
timeFrame: From implant up to 5 years (collected until 24 month FU)
Secondary outcomes:
measure: Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline
timeFrame: 12 months post-implant
measure: Impact on Quality of Life Compared to Baseline
timeFrame: Up to 5 years post-implant
measure: Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline
timeFrame: 12 months post implant
measure: Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
timeFrame: Up to 2 years (collected until 6M FU)
Other outcomes:
measure: Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea
timeFrame: screening
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Bad Oeynhausen
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Mitte
city: Darmstadt
country: Germany
facility: Alice Hospital
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein
city: Lünen
country: Germany
facility: Klinikum Lünen - St Marien Hospital
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital de Monteprincipe
Study officials:
affiliation: Bielefeld-Klinikum
name: Christoph Stellbrink
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum Göttingen
name: Stefan Anker
role: PRINCIPAL_INVESTIGATOR
References: