Sleep ApneaTREAT-CSANCT02577445
The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice
An observational study of Sleep Apnea and Central Sleep Disordered Breathing, run by LivaNova at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Central Sleep Disordered Breathing
- How many people
- 31 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2016to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with central sleep apnea
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany7 sites
Herz- und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen
Klinikum Bielefeld Mitte
Bielefeld
Alice Hospital
Darmstadt
Albertinen Krankenhaus
Hamburg
Universitaetsklinikum Schleswig Holstein
Kiel
Klinikum Lünen - St Marien Hospital
Lünen
St. Vincenz-Krankenhaus
Paderborn
Spain3 sites
Hospital Infanta Cristina
Badajoz
Hospital Universitario de Burgos
Burgos
Hospital de Monteprincipe
Madrid
About this study
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.
Read the 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
- to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea
- to collect safety information of all patients diagnosed with central sleep apnea
- 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
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CSA patients without remedē system | For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. | |
| CSA patients with remedē system | For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits. Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up. Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Collect short and long term clinical data on safety of the remede system implanted in daily practice.
This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
Measured: From implant up to 5 years (collected until 24 month FU)
Secondary outcomes (4)
Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline
Evaluate changes in sleep study results at 12 months compared to baseline
Measured: 12 months post-implant
Impact on Quality of Life Compared to Baseline
Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients
Measured: Up to 5 years post-implant
Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline
Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline
Measured: 12 months post implant
Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system
Measured: Up to 2 years (collected until 6M FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Commercial distribution of the remedē System stopped by LivaNova.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Respicardia, Inc.
- Responsible party
- Sponsor
- Investigators
- Christoph Stellbrink, Principal investigator, Bielefeld-KlinikumStefan Anker, Principal investigator, Herzzentrum Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577445
- Sponsor's protocol ID
- NVNS03
- Acronym
- TREAT-CSA
- Status last verified
- Apr 2017
- First submitted
- 25 Sep 2015
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice
- ClinicalTrials.gov ID
- NCT02577445
- Acronym / sponsor ID
- TREAT-CSA / NVNS03
- Conditions
- Sleep Apnea, Central Sleep Disordered Breathing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Commercial distribution of the remedē System stopped by LivaNova.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Collaborators
- Respicardia, Inc.
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea
- to collect safety information of all patients diagnosed with central sleep apnea
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSA patients without remedē system | – | –For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. |
| CSA patients with remedē system | – | –For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits. Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up. Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with central sleep apnea
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Time frame: From implant up to 5 years (collected until 24 month FU)
Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
4 secondary outcomes
Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline
Time frame: 12 months post-implant
Impact on Quality of Life Compared to Baseline
Time frame: Up to 5 years post-implant
Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline
Time frame: 12 months post implant
Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
Time frame: Up to 2 years (collected until 6M FU)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Stellbrink principal investigator
Bielefeld-Klinikum
Stefan Anker principal investigator
Herzzentrum Göttingen
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Central Sleep Disordered Breathing, run by LivaNova at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. (time frame: From implant up to 5 years (collected until 24 month FU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.