Obstructive Sleep Apnea of AdultARCTIC-2NCT05542082
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA
A study testing CHILLS Procedure in people with Obstructive Sleep Apnea of Adult, run by Cryosa, Inc. at 2 sites in Panama.
Trial summary
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- CHILLS Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesPanama
- Study dates
- 1 Aug 2022to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study.
- A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility.
- Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy
- BMI of 25 - 40 kg/m2 at enrollment
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell.
Who cannot join
- Unable or incapable of providing informed written consent
- Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Trial locations and contacts
2 sites in 1 country.
Panama2 sites
Punta Pacifica Hospital
Panama City, Provincia de Panamá
Paitilla Medical Center
Panama City
About this study
Official title: OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:
- Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
- Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
Read the detailed description
The study will enroll up to 3 sites in Latin America, enrollment is competitive.
Up to 70 subjects will receive treatment and be followed through their 3-month visit.
Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- CHILLS Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHILLS ProcedureDevice
Cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | CHILLS Procedure Receives: Device: CHILLS Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Procedure-Related Complications
No serious procedure-related complications including death; loss of the airway requiring post-anesthesia care unit (PACU) re-intubation; persistent loss (more than 30 days) of tongue movement; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 < 70% for > 10% of sleep.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Aug 2022
- Primary completion20 Jun 2023
- Study completion14 Sep 2023
Why it stopped: Cryosa elected to terminate the study and discontinue further follow-up after all willing and available subjects had completed the 6-month follow-up. The primary endpoint of 90-days of follow up was met for all active subjects.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryosa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stella Rowley, MD, Principal investigator, San Fernando Specialized Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542082
- Sponsor's protocol ID
- 10721
- Acronym
- ARCTIC-2
- Status last verified
- Jun 2025
- First submitted
- 13 Sep 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)
- ClinicalTrials.gov ID
- NCT05542082
- Acronym / sponsor ID
- ARCTIC-2 / 10721
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cryosa elected to terminate the study and discontinue further follow-up after all willing and available subjects had completed the 6-month follow-up. The primary endpoint of 90-days of follow up was met for all active subjects.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cryosa, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 15 Sep 2022 (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.
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:
- Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
- Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
Detailed description
The study will enroll up to 3 sites in Latin America, enrollment is competitive.
Up to 70 subjects will receive treatment and be followed through their 3-month visit.
Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: CHILLS ProcedureCHILLS Procedure |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study.
- A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility.
- Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy
- BMI of 25 - 40 kg/m2 at enrollment
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell.
Key exclusion criteria (2 listed)
- Unable or incapable of providing informed written consent
- Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
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 |
|---|---|---|
| CHILLS ProcedureCryotherapy | Device | Single Arm |
Primary outcome
Incidence of Serious Procedure-Related Complications
Time frame: 90 Days
No serious procedure-related complications including death; loss of the airway requiring post-anesthesia care unit (PACU) re-intubation; persistent loss (more than 30 days) of tongue movement; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 < 70% for > 10% of sleep.
Results and safety
The study was stopped early (reason given: Cryosa elected to terminate the study and discontinue further follow-up after all willing and available subjects had completed the 6-month follow-up. The primary endpoint of 90-days of follow up was met for all active subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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. This study is not recruiting at the moment.
Stella Rowley, MD principal investigator
San Fernando Specialized Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHILLS Procedure in people with Obstructive Sleep Apnea of Adult, run by Cryosa, Inc. at 2 sites in Panama.
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 5 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: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Panama. 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?
The study was stopped early (reason given: Cryosa elected to terminate the study and discontinue further follow-up after all willing and available subjects had completed the 6-month follow-up. The primary endpoint of 90-days of follow up was met for all active subjects.). Results are not available in the source record.
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?
Incidence of Serious Procedure-Related Complications (time frame: 90 Days). 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 26 Jun 2025.