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Janus Feasibility Study

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ClinicalTrials.gov Identifier: NCT03985527
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Transvenous nerve stimulation Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System




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.



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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

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

Sponsors and Collaborators
Respicardia, Inc.
Investigators
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Study Director: Tim Meyer, MS, PhD Respicardia, Inc.

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Responsible Party: Respicardia, Inc.
ClinicalTrials.gov Identifier: NCT03985527     History of Changes
Other Study ID Numbers: CR1389
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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