| NCT ID | NCT06556693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zoll Medical Corporation |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-12 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Severe sleep disordered breathing * Expected to tolerate study procedures * No heart failure or medically stable heart failure Exclusion Criteria: * 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
Contact & Investigator
Robin Germany, MD
STUDY DIRECTOR
ZOLL Respicardia
Frequently Asked Questions
Who can join the NCT06556693 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06556693 currently recruiting?
Yes, NCT06556693 is actively recruiting participants. Contact the research team at samuel.kolapo@zoll.com for enrollment information.
Where is the NCT06556693 trial being conducted?
This trial is being conducted at Scottsdale, United States, Wyoming, United States, Columbus, United States, Houston, United States.
Who is sponsoring the NCT06556693 clinical trial?
NCT06556693 is sponsored by Zoll Medical Corporation. The principal investigator is Robin Germany, MD at ZOLL Respicardia. The trial plans to enroll 40 participants.