Sleep Disordered BreathingPhase 2NCT01124370
Chronic Evaluation of Respicardia Therapy
A Phase 2 study testing remedē (TM) system in people with Sleep Disordered Breathing and Cheyne Stokes Respiration, run by Respicardia, Inc. at 13 sites in 4 countries.
Trial summary
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing
- What is being tested?
- remedē (TM) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 13 sitesin 4 countries
- Study dates
- May 2010to Aug 2014
- Phase
- Phase 2
- 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
Who may be able to join
- Candidate is at least 18 years old
- Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
- Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
- Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
- Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)
Who cannot join
- Candidates who are pregnant
- Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Candidates with severe COPD
- Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
- Candidates with unstable angina
- Candidates with history of primary pulmonary hypertension
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States5 sites
The Ohio State University
Columbus, Ohio
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, 17602
BryanLGH Heart Institute
Lincoln, Nebraska, 68506
St. Thomas Heart
Nashville, Tennessee
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Germany4 sites
Heart and Diabetes Center
Bad Oeynhausen
Köln University
Cologne
University of Kiel
Kiel
St. Adolf-Stift Hospital
Reinbek
Poland3 sites
Jagiellonian University
Krakow
Medical Military Institute
Warsaw
4th Military Hospital
Wroclaw
About this study
Official title: Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.
It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
- Conditions
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
- Being tested
- remedē (TM) system
- Keywords
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Cheyne-Stokes Respiration, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remedē (TM) systemDevice
Also called Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)
Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation. Receives: Device: remedē (TM) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI Change From Baseline at 3 Months
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
Measured: Baseline and 3 months on therapy
Secondary outcomes (6)
Related Adverse Events
The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.
Measured: Up to 2 years
Epworth Sleepiness Scale Change From Baseline at 6 Months
Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.
Measured: Baseline and 6 months on therapy
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.
Measured: Baseline and 6 months on therapy
Heart Failure Clinical Composite
The composite is determined according to the following definitions.
Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.
Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.
Unchanged: patient was neither improved nor worsened.
Measured: 6 months on therapy
Six-minute Hall Walk Test Change From Baseline at 6 Months
Change = Month 6 score - Baseline score
Measured: Baseline and 6 months on therapy
NYHA Functional Class Improvement From Baseline to 6 Months
Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.
NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases.
Measured: Baseline and 6 months on therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respicardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Ponikowski, MD, Principal investigator, 4th Military Clinical Hospital with Polyclinic, PolandWilliam T Abraham, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124370
- Sponsor's protocol ID
- Respicardia - Chronic Study I
- Status last verified
- Apr 2016
- First submitted
- 13 May 2010
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.
PubMed 30325462Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.
PubMed 25770408
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
- ClinicalTrials.gov ID
- NCT01124370
- Acronym / sponsor ID
- Respicardia - Chronic Study I
- Conditions
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
- Keywords
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Respicardia, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.
It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: remedē (TM) systemAll enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate is at least 18 years old
- Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
Key exclusion criteria (6 listed)
- Candidates who are pregnant
- Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Candidates with severe COPD
- Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
- Candidates with unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remedē (TM) systemAlso: Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods. | Device | Treatment |
Primary outcome
AHI Change From Baseline at 3 Months
Time frame: Baseline and 3 months on therapy
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
6 secondary outcomes
Related Adverse Events
Time frame: Up to 2 years
Epworth Sleepiness Scale Change From Baseline at 6 Months
Time frame: Baseline and 6 months on therapy
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
Time frame: Baseline and 6 months on therapy
Heart Failure Clinical Composite
Time frame: 6 months on therapy
Six-minute Hall Walk Test Change From Baseline at 6 Months
Time frame: Baseline and 6 months on therapy
NYHA Functional Class Improvement From Baseline to 6 Months
Time frame: Baseline and 6 months on therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30325462Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.
- Derived from this study: PubMed 25770408Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.
Related trials for Sleep Disordered Breathing
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
Piotr Ponikowski, MD principal investigator
4th Military Clinical Hospital with Polyclinic, Poland
William T Abraham, MD principal investigator
Ohio State University
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing remedē (TM) system in people with Sleep Disordered Breathing and Cheyne Stokes Respiration, run by Respicardia, Inc. at 13 sites in 4 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Poland, Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2015). 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?
AHI Change From Baseline at 3 Months (time frame: Baseline and 3 months on therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124370, which also lists 2 linked publications.
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 16 May 2016.