C-LIFT Efficacy in Patients With Obstructive Sleep Apnea

ConditionObstructive Sleep Apnea (OSA)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAta Murat Kaynar

About this trial

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?"

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of moderate to severe OSA (≥16 AHI events per hour)

Previously failed/refused CPAP

Not currently/actively participating in treatment for OSA

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

C-Lift
Device
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: C-LiftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Apnea-Hypopnea Index (AHI)

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.

Time frame

The device will be worn for the duration of the sleep-study, approximately 8 hours.

Participant's Description of Outcomes

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

Time frame

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.

Sponsors and contacts

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Ata Murat Kaynar

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov

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