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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Sleep Apnea, Central
• Intervention / Treatment: Device: Phrenic nerve stimulator

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • SEMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Phrenic nerve palsy.
2. Baseline hypoxia (oxygen saturation <90% on room air).
3. On supplemental oxygen.
4. Severe COPD.
5. Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement.
6. 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.

7. 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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Phrenic Nerve Stimulator; Phrenic Nerve Stimlator	Device: Phrenic nerve stimulator; Implantation of phrenic nerve stimulator; Other Names: no intervention / medical management only
No Intervention: no intervention; Patients without phrenic nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment related adverse events as assessed by CTCAEv40	Visual Analog Score for pain, BMI in Kg/m ^2	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	2 years

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Investigators: Principal Investigator: Lana Tsao, MD, Steward St. Elizabeth's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): April 29, 2019
• Study Completion (Actual): April 29, 2019

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: 00745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes