C-LIFT Efficacy in Patients With Obstructive Sleep Apnea

NCT07807124 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY25080031
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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?"

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive Sleep Apnea; C-LIFT

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

Study Arms (1)

C-Lift

EXPERIMENTAL

Participants will wear the C-Lift during sleep for one night in a sleep lab.

Device: C-Lift

Interventions

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.

C-Lift

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate to severe OSA (≥16 AHI events per hour)
• Previously failed/refused CPAP
• Not currently/actively participating in treatment for OSA

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ata Murat Kaynar: lead

Study Sites (1)

The Center for Sleep and Cardiovascular Outcomes Research (C-SCOR) Sleep Laboratory

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ata M Kaynar, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Warner, BS

CONTACT

412-623-2706; warners3@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)