An observational study in Central Sleep Apnea, sponsored by Respicardia, Inc.. Active, not recruiting at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
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 2019, is one of 7 observational ones, and was the 24th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's planned enrollment of 225 is above 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: 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. 3 started in 2019.
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 non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
Subjects who are determined to be candidates, independent of this research study, to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry 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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Time frame: 5 years
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation \<90%
Time frame: 12 months
Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy
Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy
Time frame: 5 years
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy
Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation \<90%
Time frame: 36 and 60 months
Evaluate changes in daytime sleepiness through 12 months
Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit
Time frame: 12 months
Evaluate changed in quality of life (QOL) through 12 months
Quality of life assessment including the following: * Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF subgroup only) * PROMIS-29 questionnaire change from baseline at 12, months * Patient Global Assessment (PGA) at 12 months
Time frame: 12 months
Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy
Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months.
Time frame: 12 months
Plan to share: No
Ran from Jun 2019 to primary completion in Aug 2026, 86 months.
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 86 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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