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NCT00909259 · ClinicalTrials.gov registry record · Phase 1
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
A Phase 1 study, sponsored by Respicardia.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00909259 is a Phase 1 study that has completed, run by Respicardia. The registered enrollment target is 50 participants.
The verdict
NCT00909259, a Phase 1 study, has completed, sponsored by Respicardia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Phrenic stimulation device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00909259
The ClinicalTrials.gov registry entry for NCT00909259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Respicardia, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phrenic stimulation device is the first listed.
NCT00909259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00909259 about?
NCT00909259 is a clinical study titled "Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing". 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 dayti...
What is the current status of trial NCT00909259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2007-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00909259?
The interventions under investigation include: Phrenic stimulation device (DEVICE).
Who is sponsoring clinical trial NCT00909259?
This trial is sponsored by Respicardia, which has 8 total clinical trials registered on ClinicalTrials.gov.
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