Janus II Feasibility
ConditionSleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorZoll Medical Corporation
About this trial
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
This trial does not accept healthy volunteersQualifiers
Severe sleep disordered breathing
Expected to tolerate study procedures
No heart failure or medically stable heart failure
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dual Channel Stimulation
Deviceimplant of dual channel stimulation device
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety through 12 months
Serious adverse event related to implant procedure, device, or stimulation
Time frame
12 Months post implant2
Successful Implantation
Successful Implantation of dual channel system
Time frame
implant procedure3
Improvement in sleep disordered breathing
Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.
Time frame
12 months post implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov