Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06434558 |
| Other study ID # |
855200 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
August 2030 |
Study information
| Verified date |
May 2024 |
| Source |
University of Pennsylvania |
| Contact |
Erica R Kent, BS |
| Phone |
215-615-8777 |
| Email |
erica.kent1[@]pennmedicine.upenn.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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%.
