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

Primary Purpose

Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Phrenic stimulation device

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing focused on measuring Sleep Disordered Breathing, Periodic Breathing, Cheyne-Stokes Respiration, Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Hennepin County Medical Center
Ohio Heart Hospital
The Ohio State University
Jiangsu Province Hospital
Polish Military Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phrenic Stimulation

Arm Description

Outcomes

Primary Outcome Measures

The primary goal of this feasibility study is to show an acute improvement in respiration.

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.

Secondary Outcome Measures

Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study).

Full Information

NCT ID

NCT00909259

First Posted

May 21, 2009

Last Updated

January 2, 2014

Sponsor

Respicardia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00909259

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Respicardia, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea

Keywords

Sleep Disordered Breathing, Periodic Breathing, Cheyne-Stokes Respiration, Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phrenic Stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Phrenic stimulation device

Intervention Description

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.

Primary Outcome Measure Information:

Title

The primary goal of this feasibility study is to show an acute improvement in respiration.

Time Frame

Acute (up to 2 nights of sleep)

Title

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.

Secondary Outcome Measure Information:

Title

Characterization of chronic safety of stimulating the phrenic nerve (Stage 2 of study).

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Hennepin County Medical Center

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Ohio Heart Hospital

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Jiangsu Province Hospital

City

Nanjing

Country

China

Facility Name

Polish Military Hospital

City

Wroclaw

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

22302299

Citation

Zhang XL, Ding N, Wang H, Augostini R, Yang B, Xu D, Ju W, Hou X, Li X, Ni B, Cao K, George I, Wang J, Zhang SJ. Transvenous phrenic nerve stimulation in patients with Cheyne-Stokes respiration and congestive heart failure: a safety and proof-of-concept study. Chest. 2012 Oct;142(4):927-934. doi: 10.1378/chest.11-1899.

Results Reference

derived

PubMed Identifier

21856678

Citation

Ponikowski P, Javaheri S, Michalkiewicz D, Bart BA, Czarnecka D, Jastrzebski M, Kusiak A, Augostini R, Jagielski D, Witkowski T, Khayat RN, Oldenburg O, Gutleben KJ, Bitter T, Karim R, Iber C, Hasan A, Hibler K, Germany R, Abraham WT. Transvenous phrenic nerve stimulation for the treatment of central sleep apnoea in heart failure. Eur Heart J. 2012 Apr;33(7):889-94. doi: 10.1093/eurheartj/ehr298. Epub 2011 Aug 19.

Results Reference

derived

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

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