ICE-OSA

Recruiting
99 years and younger
All
Phase N/A
10 participants needed
1 Location

Brief description of study

The primary objectives of this study are to establish if there is a relationship between successful treatment of OSA with the Cryosa Procedure and baseline quantity of oropharyngeal fat, baseline pharyngeal opening pressure (PhOP), and baseline tongue position and tongue motion. Secondary objectives of this study include assessing whether quantity of oropharyngeal fat, PhOP, or tongue position and motion change after participants undergo the Cryosa Procedure. Our primary objectives pertain to elucidate any predictors that indicate a patient would have success with the Cryosa Procedure as a treatment for their OSA. Success with the Cryosa Procedure will be defined as a reduction in AHI with an oxyhemoglobin desaturation of 4% (AHI4) of at least 50% from baseline to 6 months post-op (or to Visit 3) as measured during the PSGs that are part of the ARCTIC-3 trial. Our secondary objectives pertain to measuring the anatomical and physiological changes that result from the Cryosa Procedure as an attempt to better understand this novel OSA treatment. The secondary outcome variables will be:

        Change in the quantity of oropharyngeal fat tissue from baseline to 6 months post-op as measured by MRI scans
        Change in PhOP from baseline to 6 months post-op as measured during DISE, including the DISE from the ARCTIC-3 trial
        Change in tongue position and tongue motion from baseline to 6 months as measured by POCUS and DISE US

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 01 Aug 2024. Study ID: 855200

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