ClinicalTrials.gg
CompletedNCT03985527Updated Jan 30, 2026

Janus Feasibility Study

An interventional study of Transvenous nerve stimulation in Sleep Apnea Syndromes, sponsored by Respicardia, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Respicardia, Inc. (part of Zoll Medical Corporation) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.

Enrollment
213th of 284
29 · median 62
Started
2020
with 15 others
No phase
193 of 369
22 open now
Registered
252nd of 369
by date

Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 213th largest by enrollment of the 284 interventional ones that give a count, is one of 16 that started in 2020, is one of 193 with no phase, and was the 252nd registered.

Sleep Apnea Syndromes

1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Open to participants now

49 of the 369 studies in Sleep Apnea Syndromes with a site in United States are open now.

All 49 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 369 studies in Sleep Apnea Syndromes with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Sleep Apnea Syndromes
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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 (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 ZOLL Respicardia clinical staff
  • Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Transvenous nerve stimulation

    Device: Transvenous nerve stimulation

Interventions

  • DeviceTransvenous nerve stimulation

    Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During procedure (immediately post-stimulation)

07

Study locations

3 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Dec 2025, 71 months.

Of 68 industry-sponsored interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 71 months is above that.

Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2019
First posted
Jun 13, 2019
StartActual
Jan 9, 2020
Primary completionActual
Dec 12, 2025
CompletionActual
Dec 12, 2025
Last update
Jan 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03985527
Lead sponsor
Respicardia, Inc.
Responsible party
Sponsor
First posted
Jun 13, 2019
Start date
Jan 9, 2020
Primary completion
Dec 12, 2025
Completion
Dec 12, 2025
Last update
Jan 30, 2026

Study contacts

Kathy A McPherson, RN, MSN
study director · Respicardia, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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