Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Respicardia.
NCT00909259 is a Phase 1 study that has completed, run by Respicardia. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00909259 record still lists
NCT00909259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Phrenic stimulation device is the first listed.
NCT00909259 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00909259's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia