Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive Sleep Apnea, C-LIFT
Brief summary
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?"
Detailed description
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.
Interventions
DEVICEC-Lift
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.
Sponsors
Ata Murat Kaynar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | The device will be worn for the duration of the sleep-study, approximately 8 hours. | The Apnea-Hypopnea Index (AHI) represents the number of SDB Events, like pauses in breathing (apnea) or airway obstructions (hypopnea), per hour of sleep. The AHI Score indicates the severity of the OSA symptoms, ranging from mild (AHI: \<15 events per hour), to moderate (15-30 events per hour), to severe (\>30 events per hour). A lower AHI score indicates fewer SDB events and a better quality of sleep. A higher an AHI score, means more frequent breathing interruptions, lower quality sleep and severe symptoms of OSA. Investigators will compare AHI after wearing the device and the participant's AHI prior to wearing the device. |
| Participant's Description of Outcomes | This outcome measure will be obtained from subject feedback provided after the subject has worn the device for the duration of the sleep-study, which will last approximately 8 hours. | Qualitative description of outcomes on efficacy, and comfort. (i.e. improved symptoms of sleep apnea) 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 |
Countries
United States
Contacts
CONTACTSarah E Warner, BS
PRINCIPAL_INVESTIGATORAta M Kaynar, MD, MPH
University of Pittsburgh
Outcome results
None listed