A Phase 1 interventional study of Phrenic stimulation device in Sleep Disordered Breathing, Cheyne-Stokes Respiration and Sleep Apnea, sponsored by Respicardia, Inc.. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-06.
Sponsored by Respicardia, Inc. (part of Zoll Medical Corporation) · Phase 1, Interventional, and Treatment
Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 165th largest by planned enrollment of the 284 interventional ones that give a count, is one of 17 that started in 2007, is one of 15 in phase 1, and was the 64th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →49 of the 369 studies in Sleep Apnea Syndromes 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 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →369 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 44 · Phase 3 21 · Phase 4 20
First in 1998; this study’s year is marked. 17 started in 2007.
Median enrollment 62 across the 284 interventional studies, 114 across the 82 observational. Of the 268 that completed or were terminated, 134 (50%) have results posted.
82 of 369 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 Syndromes — fewer than ten, so there is no comparison to draw.
29 of the studies in Sleep Apnea Syndromes 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 |
|---|---|
| NCT05382754Children's Hospital of PhiladelphiaHome Apnea Testing in CHildren Trial | 2026-12 |
| NCT05575401Loma Linda UniversityLateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy | 2026-12 |
| NCT02431507Michael HarrisonMagnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety | 2026-12-01 |
| NCT07908199Ouraring Inc.Oura Ring OA15 Validation | 2026-12-03 |
| NCT03278119NYU Langone HealthSleep Aging and Risk for Alzheimer's 2.0 | 2026-12-25 |
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, from their registry updates:
The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas). Clinically, these physiologic events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
Stage 1 of the study is acute in nature, such that subjects will undergo the placement of a stimulation lead, followed by assessment of stimulation of the phrenic nerve using the lead for up to 2 nights of sleep. A sensing lead may also be placed during the initial implant procedure. Observational data will be obtained and stimulation provided using an externalized system connected to the study leads. Following the study, all investigational components will be removed from the patient.
Stage 2 of the study is being conducted at one of the participating sites to determine the initial safety of chronic stimulation of the phrenic nerve in a limited number of patients with sleep disordered breathing. It is anticipated that data obtained in this feasibility 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 a multi-center study of chronic phrenic nerve pacing.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Phrenic stimulation device
In Stage 1, a stimulation lead will be introduced via standard access methods and positioned to provide stimulation. A second lead may also be placed for sensing purposes. The proximal portions of the implanted lead(s) will remain externalized such that stimulation and observation can be made using external stimulation and recording equipment. Study subjects will be observed and stimulation will be performed for up to 2 nights of sleep in a clinically supported environment. In Stage 2, a stimulation device and lead will be permanently implanted.
The primary goal of this feasibility study is to show an acute improvement in respiration.
Time frame: Acute (up to 2 nights of sleep)
The primary safety endpoint of the study is the absence of adverse events related to stimulation that result in hospitalization, the prolongation of an existing hospitalization, or death of the patient.
Time frame: Acute (up to 2 nights of sleep) plus post-operative assessment at one week (5-10 days) or until resolution of an observed adverse event.
Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study).
Time frame: 2 years
The record gives a start of Oct 2007, a primary completion of Sep 2010 and a completion of Dec 2013. 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 completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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