Obstructive Sleep Apnea of AdultARCTIC-1NCT04864652
Safety and Dosing Study of the CHILLS Cryotherapy 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 2 countries.
Trial summary
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA. Read more about this study
- Who is it for?
- Ages 22 to 65 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
- 84 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Nov 2020to 6 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 - 65 years.
- Diagnosed with moderate to severe OSA based on history and physical or have an established diagnosis of OSA (AHI ≥ 15 and ≤ 50) based on a prior sleep study.
- BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.
Who cannot join
- Subjects with a high percentage of central apneas suggesting heart failure.
- Contraindication to general anesthesia and MRI.
- Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
- Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
- Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
- Tonsil size ≥ +3.
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- Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
- Oral cancer or non-healing oral wounds.
- Presence of symptoms of influenza-like symptoms.
- Contra-indicated for anesthesia or surgery.
- History of surgery affecting the tongue (TORS, semi-glossectomy, RFBOT, MMA, HGNS).
- History of radiation therapy to neck or upper respiratory tract
- Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
- Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
- Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
- Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 month) myocardial infarction or severe cardiac arrhythmias.
- Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.
- Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 12 months.
- History or current clinical evidence of TIA or stroke or muscular dysfunction.
- Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture, such examples being benzodiazepines, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse.
- History of dementia or active psychiatric disease that may impact study compliance.
- Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
- Unable and/or unwilling to comply with study requirements or to provide written informed consent.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.
Read the detailed description
The study is a safety and dose titration study to determine the optimum dose of Cryosa CHILLS cryotherapy in patients with clinically diagnosed moderate or severe OSA.
Up to 70 subjects are planned to be enrolled and treated with the device at up to 3 clinical sites in Latin America. Subjects will be followed for 90 days with evaluation intervals at discharge, 7 days, 30 days and 90 days post-procedure. Subjects agreeing to long-term follow-up will complete visits every 6 months through 2 years post-procedure.
- 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
CHILLS Cryotherapy procedure
| 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, or bleeding requiring surgical intervention or transfusion.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start30 Nov 2020
- Primary completion25 Aug 2022
- Study completion6 May 2023
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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryosa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marquito Caballero, MD, Principal investigator, Sanatorio AmericanoStella Rowley, MD, Principal investigator, San Fernando Specialized Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864652
- Sponsor's protocol ID
- 10419
- Acronym
- ARCTIC-1
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
- Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1
- ClinicalTrials.gov ID
- NCT04864652
- Acronym / sponsor ID
- ARCTIC-1 / 10419
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cryosa, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 29 Apr 2021 (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.
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.
Detailed description
The study is a safety and dose titration study to determine the optimum dose of Cryosa CHILLS cryotherapy in patients with clinically diagnosed moderate or severe OSA.
Up to 70 subjects are planned to be enrolled and treated with the device at up to 3 clinical sites in Latin America. Subjects will be followed for 90 days with evaluation intervals at discharge, 7 days, 30 days and 90 days post-procedure. Subjects agreeing to long-term follow-up will complete visits every 6 months through 2 years post-procedure.
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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25 - 65 years.
- Diagnosed with moderate to severe OSA based on history and physical or have an established diagnosis of OSA (AHI ≥ 15 and ≤ 50) based on a prior sleep study.
- BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.
Key exclusion criteria (23 listed)
- Subjects with a high percentage of central apneas suggesting heart failure.
- Contraindication to general anesthesia and MRI.
- Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
- Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
- Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
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 ProcedureCHILLS Cryotherapy procedure | Device | Single Arm |
Primary outcome
Incidence of Serious Procedure-Related Complications
Time frame: 30 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, or bleeding requiring surgical intervention or transfusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Marquito Caballero, MD principal investigator
Sanatorio Americano
Stella Rowley, MD principal investigator
San Fernando Specialized Center
2 sites in 2 countries: 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 2 countries.
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 4 inclusion and 23 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: finished, 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, Paraguay. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 30 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.