Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06434558
Status
Enrolling By Invitation

Conditions

  • Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryosa Procedure — PROCEDURE
    The Cryosa Procedure is part of the ARCTIC-3 protocol (IRB #854182). Therefore, all patients enrolled in this study are expected to undergo the Cryosa Procedure. Undergoing the Cryosa Procedure is not a part of this protocol.

Study Details

The goal of this observational study is to further evaluate the efficacy and mechanism of action of the Cryosa Procedure, a novel procedure intended to treat obstructive sleep apnea (OSA). The patient population includes participants with OSA who are enrolled in the ARCTIC-3 study and are undergoing the Cryosa Procedure. The main questions to be answered are: (1) evaluate predictors of successful treatment with the Cryosa Procedure, which is described in more detail in the ARCTIC-3 protocol (IRB #854182), and (2) evaluate a potential mechanism of action of this novel therapy. The study team hypothesizes that higher baseline quantities of oropharyngeal fat and higher baseline upper airway neurotonic activity will be correlated with a successful reduction in OSA symptom severity as measured by a change in apnea-hypopnea index values. The study team also hypothesizes that responders will have a decrease in oropharyngeal fat, which would indicate the mechanism of action of this novel therapy is a loss in oropharyngeal fat. Participants will be asked to: 1. have an MRI before undergoing the Cryosa Procedure 2. have an ultrasound before the Cryosa Procedure 3. permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol 4. have an MRI after the Cryosa Procedure 5. have an ultrasound after the Cryosa Procedure.

Key Dates

Start date
Jun 12, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Aug 31, 2030

Study Design

Enrollment
10 participants (estimated)

Primary Outcome Measure

Change from Baseline in Oropharyngeal Fat at 6 Months [ Time Frame: Baseline and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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