A Phase 2 interventional study of remedē (TM) system in Sleep Disordered Breathing, Cheyne Stokes Respiration and Periodic Breathing, sponsored by Respicardia, Inc.. Completed at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-16.
Sponsored by Respicardia, Inc. (part of Zoll Medical Corporation) · Phase 2, Interventional, and Treatment
Among 36 studies in Sleep Apnea, Central with a site in United States — 4 open to participants now, 6 under way, none of them phase 3. Sleep Apnea, Central · United States.
Among the 36 studies in Sleep Apnea, Central with a site in United States, this one is the 12th largest by enrollment of the 29 interventional ones that give a count, is one of 5 that started in 2010, is one of 5 in phase 2, and was the 7th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's enrollment of 57 is above the median of 40 across 54 interventional studies indexed under Sleep Apnea, Central.
Browse Sleep Apnea, Central studies →4 of the 36 studies in Sleep Apnea, Central with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Sleep Apnea, Central studies recruiting now, 8 (62%) set no upper age limit and 3 (23%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →36 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2010.
Median enrollment 44 across the 29 interventional studies, 92 across the 7 observational. Of the 28 that completed or were terminated, 18 (64%) have results posted.
18 of 36 have an industry lead sponsor. The 10 most frequent:
Respicardia, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Respicardia, Inc. has 5 studies filed under Sleep Apnea, Central — fewer than ten, so there is no comparison to draw.
2 of the studies in Sleep Apnea, Central with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06776432ShionogiSafety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea | 2026-12-31 |
| NCT04118387VA Office of Research and DevelopmentCentral Sleep Apnea : Physiologic Mechanisms to Inform Treatment | 2026-12-31 |
Among the 36 studies in Sleep Apnea, Central with a site in United States, from their registry updates:
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.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's enrollment of 57 is above the median of 40 across 54 interventional studies indexed under Sleep Apnea, Central.
Browse Sleep Apnea, Central studies →Respicardia, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted before Respicardia, Inc. became part of Zoll Medical Corporation.
Compared within Sleep Apnea, Central, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Apnea Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.
Device: remedē (TM) system
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.
Also known as: Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)
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.
Time frame: Baseline and 3 months on therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months on therapy
Six-minute Hall Walk Test Change From Baseline at 6 Months
Change = Month 6 score - Baseline score
Time frame: 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.
Time frame: Baseline and 6 months on therapy
| Milestone | Treatment |
|---|---|
| Started | 57 |
| Successfully implanted | 50 |
| Therapy initiated | 48 |
| 3 month visit | 47 |
| Completed | 37 |
| Not completed | 20 |
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.
| events/hour | Treatment |
|---|---|
| AHI Change From Baseline at 3 Months | -27.1 ± 17.7 |
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.
| participants | Treatment |
|---|---|
| Serious | 18 |
| Non-Serious | 23 |
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.
| units on a scale | Treatment |
|---|---|
| Epworth Sleepiness Scale Change From Baseline at 6 Months | -2.0 ± 4.3 |
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.
| units on a scale | Treatment |
|---|---|
| Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months | -9.9 ± 16.5 |
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.
| participants | Treatment |
|---|---|
| Improved | 20 |
| Unchanged | 9 |
| Worsened | 8 |
Change = Month 6 score - Baseline score
| meters | Treatment |
|---|---|
| Six-minute Hall Walk Test Change From Baseline at 6 Months | -7.5 ± 58.7 |
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.
| participants | Treatment |
|---|---|
| Improved | 11 |
| No change | 25 |
| Worsened | 0 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 41/57 (71.9%) | 35/57 (61.4%) |
| Event | Treatment |
|---|---|
| ACUTE CONGESTIVE HEART FAILURECardiac disorders | 14/57 |
| LEAD DISLODGEMENTGeneral disorders | 11/57 |
| VENTRICULAR ARRHYTHMIACardiac disorders | 6/57 |
| ACUTE CORONARY SYNDROMECardiac disorders | 3/57 |
| ATRIAL ARRHYTHMIACardiac disorders | 2/57 |
| CHEST PAINCardiac disorders | 2/57 |
| CORONARY ARTERY DISEASECardiac disorders | 2/57 |
| CLOSTRIDIAL ENTERITISGastrointestinal disorders | 2/57 |
| EXTRA-RESPIRATORY STIMULATIONGeneral disorders | 2/57 |
| LEAD COMPONENT FAILUREGeneral disorders | 2/57 |
| Event | Treatment |
|---|---|
| DIAPHRAGMATIC STIMULATION DISCOMFORTGeneral disorders | 16/57 |
| URINARY TRACT INFECTIONRenal and urinary disorders | 6/57 |
| ACUTE CONGESTIVE HEART FAILURECardiac disorders | 3/57 |
| EXTRA-RESPIRATORY STIMULATIONGeneral disorders | 3/57 |
| PAINGeneral disorders | 3/57 |
| HEMATOMAVascular disorders | 3/57 |
| HYPOTENSIONVascular disorders | 3/57 |
All subjects with an implant attempt.
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 66.3 ± 9.4 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 6 |
| Male | 51 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 19 |
| Poland | 17 |
| Germany | 18 |
| Italy | 3 |
| Apnea-Hypopnea Index (AHI)(events/hour) | Treatment |
|---|---|
| Mean | 49.1 ± 15.0 |
| Epworth Sleepiness Scale (ESS)(units on a scale) | Treatment |
|---|---|
| Mean | 8.6 ± 4.4 |
| Minnesota Living with Heart Failure Questionnaire (MNLHF)(units on a scale) | Treatment |
|---|---|
| Mean | 41.4 ± 18.9 |
| Six minute hall walk(meters) | Treatment |
|---|---|
| Mean | 377.8 ± 144.5 |
| New York Heart Association (NYHA) Functional Class(participants) | Treatment |
|---|---|
| Not applicable | 11 |
| Class I | 4 |
| Class II | 28 |
| Class III | 13 |
| Class IV | 1 |
7 further baseline measures are reported on the registry.
The record gives a start of May 2010, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2015, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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