Sleep ApneaNCT06556693
Janus II Feasibility
A study testing Dual Channel Stimulation in people with Sleep Apnea, run by Zoll Medical Corporation at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Dual Channel Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Aug 2025to Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
Who cannot join
- Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
- History of severe COPD 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Janus II Study contact
United States4 sites, 4 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Kalyn Ferguson, Kalyn.Ferguson@osumc.edu
Ralph Augostini, MD
- Recruiting
Houston Methodist Institute
Houston, Texas, 77030
Chinwe Ngumezi, ccngumezi@houstonmethodist.org
Paul Schurmann, MD
- Recruiting
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, Arizona, 85255
Claudia Mendoza, 4807453547, cmendoza@sleeplessinarizona.com
Sriharsha Vajjala, MD
- Recruiting
The University of Michigan Health-West
Wyoming, Michigan, 49519
Stefanie Davis, Stefanie.Davis@umhwest.org
Timothy Daum, MD
About this study
Official title: Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
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.
- Conditions
- Sleep Apnea
- Being tested
- Dual Channel 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.
Dual Channel StimulationDevice
implant of dual channel stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: Dual Channel Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety through 12 months
Serious adverse event related to implant procedure, device, or stimulation
Measured: 12 Months post implant
Successful Implantation
Successful Implantation of dual channel system
Measured: implant procedure
Improvement in sleep disordered breathing
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Measured: 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start12 Aug 2025
- Primary completionApr 2028 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Germany, MD, Study director, ZOLL Respicardia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556693
- Sponsor's protocol ID
- CIP3429
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
- ClinicalTrials.gov ID
- NCT06556693
- Acronym / sponsor ID
- CIP3429
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 16 Aug 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Dual Channel Stimulation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
Key exclusion criteria (13 listed)
- Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
- History of severe COPD 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
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 |
|---|---|---|
| Dual Channel Stimulationimplant of dual channel stimulation device | Device | Intervention group |
Primary outcome
Safety through 12 months
Time frame: 12 Months post implant
Serious adverse event related to implant procedure, device, or stimulation
Successful Implantation
Time frame: implant procedure
Successful Implantation of dual channel system
Improvement in sleep disordered breathing
Time frame: 12 months post implant
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Janus II Study contact
Robin Germany, MD study director
ZOLL Respicardia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Channel Stimulation in people with Sleep Apnea, run by Zoll Medical Corporation at 4 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 13 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Kolapo (205-441-9519, samuel.kolapo@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety through 12 months (time frame: 12 Months post implant). The study lists 3 primary outcomes in all. 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 21 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.