Sleep Apnea study: Dual Channel Stimulation
Official title Janus II Feasibility
ClinicalTrials.gov ID: NCT06556693
What this study is testing
- What it's testing
- The study aims to check if the remedē Dual Channel System is practical to use during implantation and overnight sleep studies, and to monitor its long-term safety.
- Who it's for
- The study is looking for people with sleep apnea who are interested in trying a new device.
- What's involved
- Participants will have the device implanted and undergo overnight sleep studies to monitor how it performs.
- Time commitment
- The study involves an implant procedure and overnight sleep tests to assess safety over time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
You likely can't join if
- 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
See the full eligibility criteria
- Severe sleep disordered breathing
- Expected to tolerate study procedures
- No heart failure or medically stable heart failure
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Wyoming, Michigan, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Wyoming, Michigan, United States; Columbus, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.