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
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