Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Invicta Medical Inc.
With
Vanderbilt University Medical Center
Age
21–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject must be eligible for an OSA diagnostic or surgical procedure.
Subject suffers with moderate to severe OSA based on history and a physical exam.
Subject has failed, refused or has not tolerated CPAP treatment.
Subject is willing and capable of providing informed consent.
Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
--Subject is willing to participate in the designated follow-up visits.
Subject must be in good general health.
Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
Subject must be minimum of 21 years and maximum 80 years of age.
Subject's Hypoglossal Nerve must be able to be visualized using ultrasound
You may not be if
Subject has Body Mass Index above 38kg/m2.
Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.
Clareo Health | Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
