COMPLETED

Janus Feasibility Study

Talk to us

Conditions

Sleep Apnea Syndromes

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.

Official Title

Transvenous Nerve Stimulation Study (Janus Study)

Quick Facts

Study Start:2020-01-09
Study Completion:2025-12-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03985527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is at least 18 years old
  2. * Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
  3. * Subject is willing and able to give informed consent
  1. * Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed)
  2. * 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 implant)
  3. * Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
  4. * Subject has body mass index (BMI) \> 40 kg/m2 at the time of implant
  5. * Subject has had prior neck surgery
  6. * Previous or currently implanted upper airway stimulation device
  7. * Subject has had prior oral cavity surgery that may interfere with breathing
  8. * Subject has significant upper airway-related anatomic anomaly
  9. * Subject is enrolled in concurrent study that may confound the results of this study
  10. * Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff
  11. * Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue

Contacts and Locations

Principal Investigator

Kathy A McPherson, RN, MSN
STUDY_DIRECTOR
Respicardia, Inc.

Study Locations (Sites)

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27013
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, 19010
United States

Collaborators and Investigators

Sponsor: Respicardia, Inc.

  • Kathy A McPherson, RN, MSN, STUDY_DIRECTOR, Respicardia, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-09
Study Completion Date2025-12-12

Study Record Updates

Study Start Date2020-01-09
Study Completion Date2025-12-12

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep Apnea Syndromes