Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2010

Study Completion Date

December 31, 2013

Conditions
Sleep Disordered BreathingCheyne-Stokes RespirationSleep Apnea
Interventions
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.

Trial Locations (5)

Unknown

Hennepin County Medical Center, Minneapolis

Ohio Heart Hospital, Cincinnati

The Ohio State University, Columbus

Jiangsu Province Hospital, Nanjing

Polish Military Hospital, Wroclaw

All Listed Sponsors
lead

Respicardia, Inc.

INDUSTRY

NCT00909259 - Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing | Biotech Hunter | Biotech Hunter