Sleep Apnea SyndromesNCT03985527
Janus Feasibility Study
A study testing Transvenous nerve stimulation in people with Sleep Apnea Syndromes, run by Respicardia, Inc. at 3 sites in United States.
Trial 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 or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Transvenous nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jan 2020to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years old
- 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
- Subject is willing and able to give informed consent
Who cannot join
- 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)
- 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)
- 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
Show all 11Show fewer
- 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 ZOLL Respicardia clinical staff
- Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, 19010
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27013
About this study
Official title: Transvenous Nerve Stimulation Study (Janus Study)
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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Transvenous nerve stimulation
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvenous nerve stimulationDevice
Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).
| Study group | Role | What they receive |
|---|---|---|
| Transvenous nerve stimulation | Experimental | Not described Receives: Device: Transvenous nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in respiration and airway physiology
The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.
Measured: During procedure (immediately post-stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start9 Jan 2020
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an acute, prospective, non-randomized, single arm IDE feasibility study.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respicardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy A McPherson, RN, MSN, Study director, Respicardia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985527
- Sponsor's protocol ID
- CR1389
- Status last verified
- Jan 2026
- First submitted
- 7 Jun 2019
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvenous Nerve Stimulation Study (Janus Study)
- ClinicalTrials.gov ID
- NCT03985527
- Acronym / sponsor ID
- CR1389
- Conditions
- Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Respicardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an acute, prospective, non-randomized, single arm IDE feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Transvenous nerve stimulation | Experimental | Device: Transvenous nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 18 years old
- 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
- Subject is willing and able to give informed consent
Key exclusion criteria (11 listed)
- 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)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvenous nerve stimulationAcute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator). | Device | Transvenous nerve stimulation |
Primary outcome
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 or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea Syndromes
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Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
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UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
Obstructive Sleep Apnea, Obesity
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Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
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Functional Capacity in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy A McPherson, RN, MSN study director
Respicardia, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvenous nerve stimulation in people with Sleep Apnea Syndromes, run by Respicardia, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in respiration and airway physiology (time frame: During procedure (immediately post-stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 3 Nov 2026.