Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434558
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICE-OSA
Brief 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 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
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
Detailed 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 The study team hypothesizes 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 investigators seek independent variables with large effect sizes to update and enhance patient selection criteria for the future trial
The study team propose use of Students t-test for respondersnon-responders responder defined as reduction of AHI by gt50 for the surgical intervention The expected ratio of responders to non-responders is 11 based on data provided by the study sponsor unpublished
Previous data examining tongue fat in MRI demonstrated values of quantity of fat tissue in fatty tongues to be roughly 14000 mm3 and fat tissue in non-fatty tongues to be roughly 7000 mm3 Using these parameters it was calculated that 10 subjects total would be required assuming a standard deviation of 4000 mm3 to detect significant differences between respondersnon-responders with an alpha of 005 and a power of 80
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 The study team hypothesizes 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 investigators seek independent variables with large effect sizes to update and enhance patient selection criteria for the future trial
The study team propose use of Students t-test for respondersnon-responders responder defined as reduction of AHI by gt50 for the surgical intervention The expected ratio of responders to non-responders is 11 based on data provided by the study sponsor unpublished
Previous data examining tongue fat in MRI demonstrated values of quantity of fat tissue in fatty tongues to be roughly 14000 mm3 and fat tissue in non-fatty tongues to be roughly 7000 mm3 Using these parameters it was calculated that 10 subjects total would be required assuming a standard deviation of 4000 mm3 to detect significant differences between respondersnon-responders with an alpha of 005 and a power of 80
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None