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
Qualifiers
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
Treatments tested in this trial
- Dual Channel Stimulation
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov