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Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea (STIMULATE-CSA)

Primary Purpose

Sleep Apnea, Central, Heart Failure

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phrenic nerve stimulator

About this trial

This is an interventional treatment trial for Sleep Apnea, Central

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Male or female, age 18 to 80 years inclusive.
2. New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode of heart failure requiring hospitalization in the past 24 months.
3. Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment.
4. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of >15/hour with >50% being central apneas.
5. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.

Exclusion Criteria:

Phrenic nerve palsy.
Baseline hypoxia (oxygen saturation <90% on room air).
On supplemental oxygen.
Severe COPD.
Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement.
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.
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Sites / Locations

SEMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Phrenic Nerve Stimulator

no intervention

Arm Description

Phrenic Nerve Stimlator

Patients without phrenic nerve stimulation

Outcomes

Primary Outcome Measures

Number of participants with treatment related adverse events as assessed by CTCAEv40

Visual Analog Score for pain, BMI in Kg/m ^2

Secondary Outcome Measures

Improvement in quality of life with phrenic nerve stimulation in patients with central sleep apnea and heart failure

Physicians Global Assessments to measure quality of life,

Full Information

NCT ID

NCT03238937

First Posted

July 17, 2017

Last Updated

February 25, 2020

Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03238937

Brief Title

Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

Acronym

STIMULATE-CSA

Official Title

Treatment of Central Sleep Apnea in Patients With Heart Failure With a Cervically Implanted Phrenic Nerve Stimulator

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No eligible subjects were identified.

Study Start Date

October 5, 2017 (Actual)

Primary Completion Date

April 29, 2019 (Actual)

Study Completion Date

April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The study objectives are to demonstrate the ease and safety of bilateral cervically implanted phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a form of hypoventilation syndrome, for which this device is FDA approved. We will also determine if the patient's quality and duration of life is improved by using the PNS to treat CSA in heart failure patients.

Detailed Description

This is a multi-center prospective cohort study to monitor the effect of bilateral phrenic nerve stimulation for treatment of central sleep apnea (CSA) in patients with heart failure. There will be 2 groups of study patients, both with CSA and heart failure. One group will receive the phrenic nerve pacer, and one will not. Both groups will have the same medical oversight, management, and assessment of heart health whether they receive the pacer or not. Subjects will have a physical exam, review of medications, New York Heart Association (NYHA) functional classification assessment for heart failure, Minnesota Living With Heart Failure (MLWHF) Questionnaire for quality of live assessment and blood test for Pro-BNP. In-lab sleep study will be required if subject haven't had one within 3 months, and Echocardiogram, if subjects haven't had one within 30 days. If subjects are willing to have stimulator placement procedure, they'll have an ENT consult. Subjects in the procedure arm will have Phrenic Nerve Stimulator placement procedure, and 3 weeks after procedure follow up visit with ENT doctor to activate the device and have sleep study to confirm proper settings.

6. Conditions and Keywords

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

Sleep Apnea, Central, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phrenic Nerve Stimulator

Arm Type

Other

Arm Description

Phrenic Nerve Stimlator

Arm Title

no intervention

Arm Type

No Intervention

Arm Description

Patients without phrenic nerve stimulation

Intervention Type

Device

Intervention Name(s)

Phrenic nerve stimulator

Other Intervention Name(s)

no intervention / medical management only

Intervention Description

Implantation of phrenic nerve stimulator

Primary Outcome Measure Information:

Title

Number of participants with treatment related adverse events as assessed by CTCAEv40

Description

Visual Analog Score for pain, BMI in Kg/m ^2

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Improvement in quality of life with phrenic nerve stimulation in patients with central sleep apnea and heart failure

Description

Physicians Global Assessments to measure quality of life,

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Male or female, age 18 to 80 years inclusive. 2. New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode of heart failure requiring hospitalization in the past 24 months. 3. Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment. 4. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of >15/hour with >50% being central apneas. 5. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative. Exclusion Criteria: Phrenic nerve palsy. Baseline hypoxia (oxygen saturation <90% on room air). On supplemental oxygen. Severe COPD. Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lana Tsao, MD

Organizational Affiliation

Steward St. Elizabeth's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

SEMC

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Will share protocol and study results

IPD Sharing Time Frame

once the protocol is approved and as data becomes available indefinitively

IPD Sharing Access Criteria

via secure website

Learn more about this trial

Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

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