No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Zoll Medical Corporation · Industry
Who this trial is looking for
This trial is looking for people with severe sleep apnea to test a device called the remedē® Dual Channel System. Participants will have the device implanted and undergo overnight sleep studies to see how well it works and to check for safety over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have severe sleep disordered breathing
I am expected to tolerate study procedures
I do not have heart failure or I have medically stable heart failure
You may not be able to join if
I currently have a neurostimulator for sleep apnea without approval
I have a history of severe COPD or pulmonary arterial hypertension
I have had nerve injury or palsy
I have had cervical surgeries or radiation to my head
I need an MRI
I have a history of psychosis or severe bipolar disorder
I have an active infection or sepsis within the last 30 days
I am currently on kidney dialysis or have reduced kidney function
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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 CO…
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
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