An observational study in Central Sleep Apnea and Heart Failure, sponsored by Respicardia, Inc.. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-07.
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 2 that started in 2011, is one of 7 observational ones, and was the 11th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's enrollment of 5 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: 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 2011.
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:
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients.
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).
Primary care clinic
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
Heart Failure patients with moderate to severe central sleep apnea
Apnea-hypopnea index and its components
The primary objective of the study is to determine the natural progression of central sleep apnea, using the apnea-hypopnea index (AHI) and its components evaluated at 6 months.
Time frame: 6 months
Clinical status associated with sleep disordered breathing
* Epworth Sleepiness Scale * Subject Global Assessment * Quality of life as measured by Minnesota Living with Heart Failure Questionnaire * HF Clinical Composite * Six-minute hall walk * NYHA Functional Class * Echocardiographic measures of structure and function * Subject medications
Time frame: 6 months
The record gives a start of Aug 2011, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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