Completed Studies
Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea on Sympathetic and Vascular Function
Sponsor: American Heart Association and American Academy of Sleep Medicine
CARDIOSA-12
The relationship between obstructive sleep apnea (OSA) and cardiovascular diseases is well-established. This study investigates the effect of hypoglossal nerve stimulation (HGNS) on blood pressure and other heart-related measures in people with OSA. Patients who participated had cardiovascular functions tested after a period of “regular” HGNS treatment and after a period of “sham” HGNS treatment. The results of cardiovascular tests were compared between these two periods.
Characterizing Mechanisms of Upper Airway Obstruction During Drug-Induced Sleep Endoscopy
Sponsor: National Institutes of Health
DISE-CAD
Drug-induced sleep endoscopy (DISE) is a procedure used by Otolaryngologists to evaluate upper airway collapse site(s) of patients with obstructive sleep apnea. Our National Institutes of Health (NIH) sponsored study aims to characterize specific causes of upper airway obstruction during DISE. Our approach involves measuring airway pressures, pharyngeal patency, airflow, and responses to tongue muscle stimulation during DISE. Our goal is to develop personalized solutions that address the pathogenic mechanisms of airway collapse and airflow obstruction during sleep.
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Sponsor: Inspire Medical Systems, Inc.
ADHERE
This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe, enrolling up to 5,000 people. The purpose of the registry is to gather information on how the device is used and performs for patients in the commercial setting. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the final follow-up timeframe. In addition, the information collected will help to educate physicians who treat obstructive sleep apnea. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.
Assessing diagnostic predictors of airway collapse in patients with Obstructive Sleep Apnea
Sponsor: Inspire Medical Systems, Inc.
ADHERE
This study is an exploratory, multicenter study of data from up to 600 subjects diagnosed with OSA who are being evaluated for airway surgery and meet indications for implant of the Inspire Upper Airway Stimulation System. Evaluation for airway surgery includes a standard airway assessment and a Drug-Induced Sleep Endoscopy (DISE), to determine appropriate anatomical obstruction for implant (absence vs presence of concentric collapse at the soft palate). The VOTE Classification (based on DISE findings) is used to determine the degree of obstruction. The VOTE Classification for each patient will be recorded at the time of the DISE. During the standard airway assessment, a simple, non-invasive measurement of the pharyngeal width (PW) will be performed.
