Ata Murat Kaynar
The goal of this clinical trial is to evaluate the efficacy of the C-Lift Device as a non-invasive treatment for Sleep Disordered Breathing (SDB) within the population of adults diagnosed with moderate to severe Obstructive Sleep Apnea (OSA), who are not currently being treated with a Continuous Positive Airway Pressure (CPAP) device or other intervention. This study aims to answer 2 main questions: "Will C-Lift demonstrate a qualitative improvement in a participant's perception/description of their sleep-quality?" And, "Will wearing the C-Lift Device overnight show a quantitative improvement in a participant's oxygen saturation?"
The validated "Standford Sleepiness Scale", Richards-Campbell Sleep Questionnaire, and "PROMIS- Sleep Disturbance Short Form-8a" (also referred to as the "DSM-5-TR Level 2- Sleep Disturbance- Adult Measure") will be used pre- and post-intervention to establish the participant's perception of their sleep-quality during the overnight study compared to their baseline. A custom "C-Lift Efficacy Questionnaire" will be given post-intervention to document the participant's experience with the device and assess their ability to tolerate wearing the device. The quantitative impact of the C-Lift Device…
Inclusion Criteria: * Diagnosis of moderate to severe OSA (≥16 AHI events per hour) * Previously failed/refused CPAP * Not currently/actively participating in treatment for OSA Exclusion Criteria: * Diagnosis of mild OSA (AHI\<15 events per hour) * Received treatment for OSA in the 2-weeks prior to the sleep-study EX: CPAP, other oral device * Received prior surgical treatment for OSA EX: hypoglossal nerve stimulation (NOT including Tonsillectomy) * Diagnosis of comorbid sleep disorder EX: Insomnia * History of other sleep-disordered breathing EX: central sleep apnea, hypoventilation syndro…
The Head-Tilt, Chin-Lift Positioning Device (C-Lift) is embedded with a variety of sensors to detect SDB events and OSA symptoms. Audible snoring, sounds of gasping, or decreased oxygen saturation will trigger the cushioned lining the neck brace, to inflate/deflate, as needed, to open the airway and maintain stable breathing.
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