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Janus Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985527
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

Study Description
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Brief Summary:
The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System implant procedure.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: Transvenous nerve stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Transvenous Nerve Stimulation Study (Janus Study)
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Transvenous nerve stimulation Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System


Outcome Measures
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Primary Outcome Measures :
  1. Changes in respiration and airway physiology [ Time Frame: During procedure (immediately post-stimulation) ]
    The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System implant.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is at least 18 years old
  • Subject with moderate to severe central sleep apnea is undergoing a commercial remedē® System implant
  • Subject is willing and able to give informed consent

Exclusion Criteria:

  • Subject is unable or unwilling to participate with study procedures
  • Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the remedē system implant)
  • Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
  • Subject has body mass index (BMI) > 40 kg/m2 at the time of implant
  • Subject has had prior neck surgery
  • Previous or currently implanted upper airway stimulation device
  • Subject has had prior oral cavity surgery that may interfere with breathing
  • Subject has significant upper airway-related anatomic anomaly
  • Subject is enrolled in concurrent study that may confound the results of this study
  • Subject is taking muscle relaxant medication unless approved by the site implanter and Respicardia clinical staff
  • Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985527


Contacts
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Contact: Scott Skorupa 952-641-4440 sskorupa@respicardia.com

Locations
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United States, North Carolina
Novant Health Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27013
Contact: Leslie Tucker    336-718-5889      
Principal Investigator: Michael Drucker, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Brougher    614-292-3962      
Principal Investigator: Ralph Augostini, MD         
United States, Pennsylvania
Bryn Mawr Medical Specialists Association Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Anne Henry    610-525-1202      
Principal Investigator: Sheetal Chandhok, MD         
Sponsors and Collaborators
Respicardia, Inc.
Investigators
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Study Director: Tim Meyer, MS, PhD Respicardia, Inc.
More Information
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Responsible Party: Respicardia, Inc.
ClinicalTrials.gov Identifier: NCT03985527    
Other Study ID Numbers: CR1389
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases