Clinical Trials Logo

Clinical Trial Summary

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 we aim to answer 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. We hypothesize 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. We also hypothesize 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.


Clinical Trial Description

Previous research has shown there is increased fat at the base of the tongue and other locations of the oropharynx in patients with Obstructive Sleep Apnea (OSA) compared to match control non-OSA patients. Subsequently, Cryosa developed the Cryosa Procedure, which is further detailed in the ARCTIC-3 protocol (IRB #854182). This procedure involves the Cryosa System, a device intended to induce adipose cryolysis, a non-surgical removal of by inducing cell death (apoptosis) with a controlled freezing of the soft tissue, in the upper airway. Whereas the objective of the ARCTIC-3 study is to determine the efficacy and safety of the Cryosa Procedure, the co-primary aims of the ICE-OSA study are to (1) evaluate predictors of successful treatment with the Cryosa Procedure and (2) evaluate a potential mechanism of action of this novel therapy. We hypothesize that (1) higher baseline quantity of oropharyngeal fat and higher baseline upper airway neurotonic activity are correlated with a successful reduction in OSA severity, and (2) responders will have a decrease in quantity of oropharyngeal fat (as measured by post-operation magnetic resonance imaging, MRI). Investigating the mechanisms and predictors of this novel therapy is necessary to inform future clinical trials and patient selection for the Cryosa Procedure. To assess these metrics, the ICE-OSA study utilizes MRI, point-of-care ultrasound (POCUS), and the addition of pharyngeal manometry and ultrasound (US) during drug-induced sleep endoscopy (DISE) for ARCTIC-3 participants. Study Statistics: These prognostic data are going to be collected as part of a small pilot study to inform the upcoming pivotal trial. For this reason, we seek independent variables with large effect sizes to update and enhance patient selection criteria for the future trial. We propose use of Student's t-test for responders/non-responders (responder defined as reduction of AHI by >50%) for the surgical intervention. Our expected ratio of responders to non-responders is 1:1 based on data provided by the study sponsor (unpublished). Our previous data examining tongue fat in MRI demonstrated values of quantity of fat tissue in fatty tongues to be roughly 14,000 mm3 and fat tissue in non-fatty tongues to be roughly 7,000 mm3. Using these parameters, we calculated that 10 subjects total would be required (assuming a standard deviation of 4,000 mm3) to detect significant differences between responders/non-responders with an alpha of 0.05 and a power of 80%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06434558
Study type Observational
Source University of Pennsylvania
Contact Erica R Kent, BS
Phone 215-615-8777
Email erica.kent1@pennmedicine.upenn.edu
Status Not yet recruiting
Phase
Start date June 2024
Completion date August 2030

See also
  Status Clinical Trial Phase
Recruiting NCT05489562 - Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea N/A
Recruiting NCT05717959 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06008626 - Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea N/A
Completed NCT03122639 - Endothelial Function in Obstructive Sleep Apnea Early Phase 1
Completed NCT03940781 - Effects of Rehabilitation for Patients With Obstructive Sleep Apnea N/A
Recruiting NCT05289063 - Vascular Endothelial Dysfunction in Sleep Apnea Phase 1
Not yet recruiting NCT05268471 - Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea N/A
Active, not recruiting NCT04864652 - Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA N/A
Enrolling by invitation NCT05433883 - The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness N/A
Recruiting NCT06103630 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06283095 - Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty N/A
Completed NCT03156283 - SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence N/A
Completed NCT03362385 - OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
Recruiting NCT06447818 - Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
Completed NCT04643782 - Comparative Study of the ANNEā„¢ One System to Diagnose Obstructive Sleep Apnea N/A
Recruiting NCT03463785 - Does Race Make a Difference in Obstructive Sleep Apnea?
Recruiting NCT03618719 - Impact of Intermittent Hypoxia on the Function of the Phagocytes
Completed NCT03048604 - BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA) N/A
Recruiting NCT05290350 - Long COVID-19 Fatigue and Obstructive Sleep Apnea
Recruiting NCT05739617 - Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea N/A