Obstructive Sleep Apnea of AdultICE-OSANCT06434558
Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea of Adult, run by University of Pennsylvania at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Cryosa Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study enrolls only participants that are previously enrolled in the ARCTIC-3 trial and are subsequently undergoing the Cryosa Procedure as part of the ARCTIC-3 protocol. As required by the eligibility criteria in the ARCTIC-3 study, these patients have a BMI less than or equal to 40 kg/m2, are 22 to 70 years old, and have moderate to severe obstructive sleep apnea (OSA). Additionally, eligibility requirements from the ARCTIC-3 trial include having never previously undergone uvulopalatopharyngoplasty or tongue base reduction for the treatment of OSA. Patients are also excluded for any other reasons the principal investigator would deem a contraindication to undergoing procedures outlined by the ARCTIC-3 protocol.
Who may be able to join
- Enrolled in the ARCTIC-3 clinical trial at the University of Pennsylvania*
- Provision of signed and dated informed consent form for ICE-OSA
Who cannot join
- MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
- Patient is pregnant or becomes pregnant during their enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read more
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:
- have an MRI before undergoing the Cryosa Procedure
- have an ultrasound before the Cryosa Procedure
- permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol
- have an MRI after the Cryosa Procedure
- have an ultrasound after the Cryosa Procedure.
Read the 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 Student's t-test for responders/non-responders (responder defined as reduction of AHI by \>50%) for the surgical intervention. The expected ratio of responders to non-responders is 1:1 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 14,000 mm3 and fat tissue in non-fatty tongues to be roughly 7,000 mm3. Using these parameters, it was 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%.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Cryosa Procedure
- Keywords
- Obstructive Sleep Apnea, ultrasound, MRI, cryotherapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryosa ProcedureProcedure or surgery
Also called Cryotherapy, OSA Cryotreatment
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Oropharyngeal Fat at 6 Months
Quantity of oropharyngeal fat will be measured with magnetic resonance imaging (MRI) before the Cryosa Procedure and 6 months after the Cryosa Procedure in all subject participants.
Measured: Baseline and 6 months
Change in Baseline Apnea Hypopnea Index at 6 Months
All participants in this study, who are also enrolled in the ARCTIC-3 study, are undergoing a polysomnogram as part of the ARCTIC-3 study at baseline and at 6 months. AHI is measured during these sleep studies in every patient at both timepoints.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start12 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Dedhia, MD, University of Pennsylvania
- Investigators
- Raj Dedhia, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434558
- Sponsor's protocol ID
- 855200
- Acronym
- ICE-OSA
- Status last verified
- Oct 2025
- First submitted
- 23 May 2024
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06434558
- Acronym / sponsor ID
- ICE-OSA / 855200
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, ultrasound, MRI, cryotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- have an MRI before undergoing the Cryosa Procedure
- have an ultrasound before the Cryosa Procedure
- permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol
- have an MRI after the Cryosa Procedure
- 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 Student's t-test for responders/non-responders (responder defined as reduction of AHI by \>50%) for the surgical intervention. The expected ratio of responders to non-responders is 1:1 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 14,000 mm3 and fat tissue in non-fatty tongues to be roughly 7,000 mm3. Using these parameters, it was 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study enrolls only participants that are previously enrolled in the ARCTIC-3 trial and are subsequently undergoing the Cryosa Procedure as part of the ARCTIC-3 protocol. As required by the eligibility criteria in the ARCTIC-3 study, these patients have a BMI less than or equal to 40 kg/m2, are 22 to 70 years old, and have moderate to severe obstructive sleep apnea (OSA). Additionally, eligibility requirements from the ARCTIC-3 trial include having never previously undergone uvulopalatopharyngoplasty or tongue base reduction for the treatment of OSA. Patients are also excluded for any other reasons the principal investigator would deem a contraindication to undergoing procedures outlined by the ARCTIC-3 protocol.
Key inclusion criteria (2 listed)
- Enrolled in the ARCTIC-3 clinical trial at the University of Pennsylvania*
- Provision of signed and dated informed consent form for ICE-OSA
Key exclusion criteria (2 listed)
- MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
- Patient is pregnant or becomes pregnant during their enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryosa ProcedureAlso: Cryotherapy, OSA CryotreatmentThe 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. | Procedure or surgery | – |
Primary outcome
Change from Baseline in Oropharyngeal Fat at 6 Months
Time frame: Baseline and 6 months
Quantity of oropharyngeal fat will be measured with magnetic resonance imaging (MRI) before the Cryosa Procedure and 6 months after the Cryosa Procedure in all subject participants.
Change in Baseline Apnea Hypopnea Index at 6 Months
Time frame: Baseline and 6 Months
All participants in this study, who are also enrolled in the ARCTIC-3 study, are undergoing a polysomnogram as part of the ARCTIC-3 study at baseline and at 6 months. AHI is measured during these sleep studies in every patient at both timepoints.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raj Dedhia, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Oropharyngeal Fat at 6 Months (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.