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NCT Number: NCT07807124

C-LIFT Efficacy 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?"

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pittsburgh, Pennsylvania, 15213, United States

Location contact

Ata M Kaynar, MD, MPH

CONTACT

[email protected]

412-692-2784

Sarah E Warner, BS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: 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.

  2. Participant's Description of Outcomes

    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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah E Warner, BS

CONTACT

[email protected]

412-623-2706

Sponsors and collaborators

Lead sponsor

Ata Murat Kaynar

Other

Registry information

Official study title

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

Acronym: EOSA

Important dates

Study start
2027
Primary completion
2027
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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