C-LIFT Efficacy in Patients With Obstructive Sleep Apnea

Efficacy Testing of Active Head Tilt Chin-Lift Positioning (C-LIFT) Device in Patients With Obstructive Sleep Apnea

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 will be measured by the Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), and the hypoxic burden of the participant recorded during the overnight study-study.

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 syndrome
• History of cervical spine injury/surgery
• Currently receiving oxygen therapy
• Baseline oxygen saturation <90%
• Currently pregnant
• History of substance abuse
• Neck circumference >20 inches
• Regular use of medications which can impact sleep-disordered breathing or related symptoms.

EX: opioids, benzodiazepines, gabapentin, antipsychotics, amphetamines or other stimulants.