An interventional study of Treatment Group (transvenous stimulation of the phrenic nerve) and Control Group (Optimal Medical Therapy) in Sleep Apnea, Central, Sleep Disordered Breathing and Heart Failure, sponsored by Respicardia, Inc.. Completed at 30 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-29.
Sponsored by Respicardia, Inc. (part of Zoll Medical Corporation) · Not applicable, 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 6th largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2013, is one of 17 with no phase, and was the 13th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's enrollment of 151 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. 2 started in 2013.
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 primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.
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.
Central Sleep apnea confirmed by core lab analysis of PSG with EEG within 40 days of scheduled implant:
Medically stable for 30 days prior to all baseline testing (including PSG), i.e., no hospitalizations for illness, no breathing mask-based therapy, and on stable medications and therapies:
Expected to tolerate study procedures in the opinion of the investigator, in particular:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects implanted with the remedē system device and randomized to the Treatment group will receive optimal medical therapy and have the remedē system initiated to deliver transvenous stimulation of the phrenic nerve at the Therapy Initiation Visit (1 month post device implant).
Device: Treatment Group (transvenous stimulation of the phrenic nerve)
Subjects implanted with the remedē system device and randomized to the Control group will receive optimal medical therapy through the 6-month Post-Therapy Initiation Visit. Control group subjects will have the remedē system initiated to deliver transvenous stimulation of the phrenic nerve at the 6-month Post-Therapy Initiation Visit (7 months post device implant).
Device: Control Group (Optimal Medical Therapy)
device implant, optimal medical therapy and device initiation 1 month post implant.
Also known as: remedē System, Transvenous stimulation of the phrenic nerve
device implant, optimal medical therapy and delayed device initiation (7 months post device implant)
Also known as: Optimal Medical Therapy
The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)
Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
Time frame: 6 months
Freedom From Related Serious Adverse Events Within 12 Months
Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.
Time frame: 12 months
Central Apnea Index (CAI) Change From Baseline at 6 Months
Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.
Time frame: 6 months
Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months
Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement 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: 6 months
Arousal Index (ArI) Change From Baseline at 6 Months
Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.
Time frame: 6 months
Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months
Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.
Time frame: 6 months
The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months
The proportion of subjects with a "moderate" or "marked" improvement in the Patient Global Assessment from baseline to the 6 month visit
Time frame: 6 months
Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months
Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.
Time frame: 6 months
Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months
Change in ESS = 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: 6 months
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 73 | 78 |
| 6 month primary effectiveness assessed | 68 | 73 |
| Completed | 60 | 70 |
| Not completed | 13 | 8 |
Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
| Participants | Treatment Group | Control Group |
|---|---|---|
| The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) | 35 | 8 |
Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.
| Participants | Pooled Group |
|---|---|
| Freedom From Related Serious Adverse Events Within 12 Months | 138 |
Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.
| Events/hour | Treatment Group | Control Group |
|---|---|---|
| Central Apnea Index (CAI) Change From Baseline at 6 Months | -25.7 (-30.5 to -21.0) | -2.9 (-7.0 to 1.2) |
Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement 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 Group | Control Group |
|---|---|---|
| Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months | -23.9 (-28.8 to -19.0) | 1.1 (-3.0 to 5.2) |
Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.
| Events/hour | Treatment Group | Control Group |
|---|---|---|
| Arousal Index (ArI) Change From Baseline at 6 Months | -20.2 (-25.2 to -15.2) | -5.0 (-9.2 to -0.8) |
Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.
| percentage of sleep | Treatment Group | Control Group |
|---|---|---|
| Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months | 1.8 (-0.3 to 4.0) | -0.6 (-2.4 to 1.3) |
The proportion of subjects with a "moderate" or "marked" improvement in the Patient Global Assessment from baseline to the 6 month visit
| Participants | Treatment Group | Control Group |
|---|---|---|
| The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months | 35 | 4 |
Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.
| Events/hour | Treatment Group | Control Group |
|---|---|---|
| Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months | -19.1 (-23.9 to -14.3) | 3.6 (-0.5 to 7.6) |
Change in ESS = 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 Group | Control Group |
|---|---|---|
| Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months | -3.6 (-5.1 to -2.1) | 0.1 (-0.9 to 1.2) |
Collected over Implant through 12 Months post therapy initiation visit window. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pooled Group | 7/151 (4.6%) | 74/151 (49%) | 53/151 (35.1%) |
| Event | Pooled Group |
|---|---|
| HEART FAILURECardiac disorders | 16/151 |
| SUSTAINED VENTRICULAR TACHY ARRHYTHMIACardiac disorders | 11/151 |
| ATRIAL FIBRILLATIONCardiac disorders | 5/151 |
| AORTIC VALVE DISEASECardiac disorders | 3/151 |
| CORONARY ARTERY DISEASECardiac disorders | 3/151 |
| IMPENDING POCKET EROSIONGeneral disorders | 3/151 |
| SEPSISInfections and infestations | 3/151 |
| FRACTUREInjury, poisoning and procedural complications | 3/151 |
| ANEMIABlood and lymphatic system disorders | 2/151 |
| CHEST PAIN - CARDIACCardiac disorders | 2/151 |
| Event | Pooled Group |
|---|---|
| DIAPHRAGMATIC STIMULATION DISCOMFORTGeneral disorders | 38/151 |
| EXTRA-RESPIRATORY STIMULATIONGeneral disorders | 14/151 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 11/151 |
Intent-to-treat
| Age, Continuous(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 65 ± 12 | 65 ± 13 | 65 ± 13 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 10 | 6 | 16 |
| Male | 63 | 72 | 135 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 72 | 74 | 146 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 70 | 74 | 144 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| United States | 49 | 50 | 99 |
| Poland | 10 | 11 | 21 |
| Germany | 14 | 17 | 31 |
| Apnea-Hypopnea Index (AHI)(Events/hour) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 48.8 ± 19.3 | 43.7 ± 16.8 | 46.2 ± 18.2 |
| Central Apnea Index (CAI)(Events/hour) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 30.0 ± 18.0 | 26.6 ± 16.1 | 28.2 ± 17.1 |
| Arousal Index (ArI)(Events/hour) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 45.5 ± 17.9 | 43.6 ± 19.1 | 44.6 ± 18.5 |
12 further baseline measures are reported on the registry.
The record gives a start of Mar 2013, a primary completion of Sep 2016 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2017, 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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