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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909259
• Other study ID #: CCI-Feasibility
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2009
• Last updated: January 2, 2014
• Start date: October 2007
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Respicardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of HealthChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient has a demonstrated history of periodic breathing (symptoms may include sleep fragmentation, as reported by patient or as witnessed by another person, night arousal after apneic episodes, reduced exercise capacity, and daytime sleepiness)

• Patient is expected to be able to tolerate the procedure and remain clinically stable for the duration of the study (e.g. the subject is able to lie down long enough to insert the lead(s) without shortness of breath and the subject is able to tolerate instrumentation during study).

• Patient or their legal representative is willing and able to sign an IRB/MEC approved informed consent (and a privacy protection authorization in the United States)

Exclusion Criteria:

• Baseline oxygen saturation less than or equal to 90% on a stable FIO2

• Evidence of phrenic nerve palsy

• Temperature > 38.0 degrees Celsius

• Inability to place catheter (e.g. previously known coagulopathy, distorted anatomy, etc.)

• Patient is currently enrolled in another study that may confound the results of this study

• Patient for whom informed consent cannot be obtained

• Patient who is pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure

• Patients implanted with a pacemaker, implantable defibrillator, or cardiac resynchronization device who are unable to tolerate turning off the device for the duration of the system testing procedure (based on medical judgment)

• Patients with severe COPD (per GOLD scale)

• Patients with a history of myocardial infarction within 6 months prior to the study

• Patients with unstable angina

• Patients who are intolerant of or allergic to contrast dye

• Patients who are contraindicated for <1mg of steroid (on the stimulation lead).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cheyne-Stokes Respiration
• Respiratory Aspiration
• Sleep Apnea
• Sleep Disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing
Poland	Polish Military Hospital	Wroclaw
United States	Ohio Heart Hospital	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Respicardia, Inc.

Countries where clinical trial is conducted

United States,  China,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary goal of this feasibility study is to show an acute improvement in respiration.		Acute (up to 2 nights of sleep)	No
Primary	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.		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.	Yes
Secondary	Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study).		2 years	Yes