An observational study in Central Sleep Apnea, sponsored by Respicardia, Inc.. Completed at 17 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Respicardia, Inc. (part of Zoll Medical Corporation) · Observational
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 one of 3 that started in 2018, is one of 7 observational ones, and was the 18th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's enrollment of 53 is below the median of 148 across 36 observational 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: 21 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. 3 started in 2018.
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:
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.
Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.
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.
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.
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.
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.
Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure.
5-Year Survival Rate
Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
Time frame: Through 5 years
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.
Time frame: Through 5 years
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.
Time frame: Through 3 and 5 years
Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years
Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).
Time frame: 5 years
Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years
Change in ESS = Year 5 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: 5 years
151 subjects enrolled in the original pivotal trial of the remede system. 94 were ongoing at the time of trial closure and therefore eligible to participate in this continuation post approval study. Pivotal trial sites with subjects ongoing at the time of study closure were invited to participate in this long-term continuation study. Subjects needed to re-consent to participate. Due to sites or subjects declining participation, not all subjects participated in this continuation study.
| Milestone | Treatment |
|---|---|
| Started | 53 |
| Completed | 52 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
| percentage of participants | Enrolled in Pivotal Trial |
|---|---|
| 5-Year Survival Rate | 78 (71 to 85) |
Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.
| Participants | Enrolled in Pivotal Trial |
|---|---|
| 3 Years | 9 |
| 5 Years | 12 |
Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.
| Participants | Enrolled in Pivotal Trial |
|---|---|
| 3 Years | 4 |
| 5 Years | 4 |
Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).
| Events/hour | Treatment |
|---|---|
| Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years | -22 (-42 to -7) |
Change in ESS = Year 5 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 (ESS) Change From Baseline at 5 Years | -3 (-8 to -1) |
Collected over The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/53 (0%) | 23/53 (43.4%) | 3/53 (5.7%) |
| Event | Treatment |
|---|---|
| HEART FAILURECardiac disorders | 3/53 |
| STROKENervous system disorders | 3/53 |
| ACUTE CORONARY SYNDROMECardiac disorders | 1/53 |
| ATRIAL FIBRILLATIONCardiac disorders | 1/53 |
| CORONARY ARTERY DISEASECardiac disorders | 1/53 |
| HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHYCardiac disorders | 1/53 |
| SINUS BRADYCARDIACardiac disorders | 1/53 |
| VENTRICULAR TACHYCARDIACardiac disorders | 1/53 |
| HYPOTHYROIDISMEndocrine disorders | 1/53 |
| INGUINAL HERNIAGastrointestinal disorders | 1/53 |
| Event | Treatment |
|---|---|
| ATRIAL FIBRILLATIONCardiac disorders | 3/53 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 63 ± 11 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 5 |
| Male | 48 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Heart failure(Participants) | Treatment |
|---|---|
| Count of participants | 29 |
| Apnea Hypopnea Index(events/hour) | Treatment |
|---|---|
| Median | 41 (34 to 57) |
| Epworth Sleepiness Scale(units on a scale) | Treatment |
|---|---|
| Median | 12 (6 to 15) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Aug 2020, 25 months.
Results were first posted in Apr 2021, 8 months after primary completion.
Of 18 observational studies under Sleep Apnea, Central, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 107. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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