ClinicalTrials.gg
RecruitingNCT06556693Updated Nov 6, 2026

Janus II Feasibility

An interventional study of Dual Channel Stimulation in Sleep Apnea, sponsored by Zoll Medical Corporation. Recruiting at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Zoll Medical Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 21, 2026Eligibility revisedStudy contact changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.

02

Conditions studied

  • Sleep Apnea
03

In context

Sleep Apnea Syndromes

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

This study's planned enrollment of 40 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 21, 2026. See what changed

Ages eligible
22 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

  • Severe sleep disordered breathing
  • Expected to tolerate study procedures
  • No heart failure or medically stable heart failure

Exclusion criteria

Exclusion Criteria:

  • Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
  • History of severe or pulmonary arterial hypertension
  • Current or previous history of nerve injury or palsy
  • Prior cervical surgeries or radiation treatment to head region
  • Known need for an MRI
  • History of psychosis or severe bipolar disorder
  • Active Infection or sepsis within 30 days of enrollment
  • Currently on kidney dialysis or significantly reduced kidney function
  • Pacemaker dependance
  • New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
  • Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
  • Allergy to contrast dye unless can be prophylactically treated
  • Known pregnancy or planning to become pregnant
Terms in these criteria, in plain language(1)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Device: Dual Channel Stimulation

Interventions

  • DeviceDual Channel Stimulation

    implant of dual channel stimulation device

06

What researchers measure

Primary outcomes

  1. Safety through 12 months

    Serious adverse event related to implant procedure, device, or stimulation

    Time frame: 12 Months post implant

  2. Successful Implantation

    Successful Implantation of dual channel system

    Time frame: implant procedure

  3. Improvement in sleep disordered breathing

    Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.

    Time frame: 12 months post implant

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates 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

Started Aug 2025 (actual). Primary completion is estimated for Apr 2028, 32 months after the start.

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 planned 32 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
Aug 8, 2024
First posted
Aug 16, 2024
StartActual
Aug 12, 2025
Primary completionEst.
Apr 2028
CompletionEst.
Dec 2034
Last update
Nov 6, 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.
Sites
1 site added
Show site
  • Houston Methodist Institute · Houston, United States
Oct 21, 2026
Eligibility
1 exclusion criterion removed
What changed in the criteria
Exclusion criteria
  • RemovedHemoglobin less than 8g/dl
Oct 21, 2026
Contact
Study contact changed: k•••@zoll.com · •••6321→J•••@zoll.com. See the current contact
Oct 21, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • The Insomnia and Sleep Institute of Arizona LLC · Scottsdale, United StatesContact r•••@sleeplessinarizona.com · •••3547→c•••@sleeplessinarizona.com · •••3547
  • The Ohio State University · Columbus, United StatesContact K•••@osumc.edu→A•••@osumc.edu
across 2 updates, Oct 21, 2026 – Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The Ohio State University · Columbus, United StatesContact K•••@osumc.edu→A•••@osumc.edu
    + 1 other change: verification date
  2. Oct 21, 2026
    1 site added
    Show site
    • Houston Methodist Institute · Houston, United States
    Eligibility 1 exclusion criterion removed
    What changed in the criteria
    Exclusion criteria
    • RemovedHemoglobin less than 8g/dl
    Contact Study contact changed: k•••@zoll.com · •••6321→J•••@zoll.com. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The Insomnia and Sleep Institute of Arizona LLC · Scottsdale, United StatesContact r•••@sleeplessinarizona.com · •••3547→c•••@sleeplessinarizona.com · •••3547
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06556693
Responsible party
Sponsor
First posted
Aug 16, 2024
Start date
Aug 12, 2025
Primary completion
Apr 2028 (estimated)
Completion
Dec 2034 (estimated)
Last update
Nov 6, 2026

Study contacts

Samuel Kolapo
Contact
samuel.kolapo@zoll.com
205-441-9519
Janus II Study
Contact
JNS02@zoll.com
Robin Germany, MD
study director · ZOLL Respicardia

Oversight

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

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