Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA (ARCTIC-1)

June 23, 2025 updated by: Cryosa, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Paitilla Medical Center
  • Paraguay
      • Asunción, Paraguay
        • Sanatorio Americano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 25 - 65 years.
  2. 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.
  3. BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
  4. Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.

Exclusion Criteria:

  1. Subjects with a high percentage of central apneas suggesting heart failure.
  2. Contraindication to general anesthesia and MRI.
  3. Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
  4. Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
  5. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
  6. Tonsil size ≥ +3.
  7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
  8. Oral cancer or non-healing oral wounds.
  9. Presence of symptoms of influenza-like symptoms.
  10. Contra-indicated for anesthesia or surgery.
  11. History of surgery affecting the tongue (TORS, semi-glossectomy, RFBOT, MMA, HGNS).
  12. History of radiation therapy to neck or upper respiratory tract
  13. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
  14. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
  15. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
  16. 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.
  17. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.
  18. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 12 months.
  19. History or current clinical evidence of TIA or stroke or muscular dysfunction.
  20. 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.
  21. History of dementia or active psychiatric disease that may impact study compliance.
  22. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
  23. Unable and/or unwilling to comply with study requirements or to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm
CHILLS Procedure
Device: CHILLS Procedure
CHILLS Cryotherapy procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of Cryotherapy on Tongue Function: Taste
Time Frame: 7 days, 30 days and 90 days
Evaluated by assessment of change (Definitely, Somewhat, Not at all) to the taste of: salt, sourness, sweetness, bitterness, savory.
7 days, 30 days and 90 days
Impact of Cryotherapy on Tongue Function: Sensation
Time Frame: 7 days, 30 days and 90 days

Evaluated by assessment of any numbness of the tongue (Yes, No; if Yes: Mild, Mild to Moderate, Moderate, Moderate to Severe, Severe) physical examination, and tests.

Evaluated by assessment of any burning of the tongue (Yes, No; if Yes: Mild, Mild to Moderate, Moderate, Moderate to Severe, Severe)
7 days, 30 days and 90 days
Impact of Cryotherapy on Tongue Function: Movement
Time Frame: 7 days, 30 days and 90 days

Evaluated by assessment of tongue movement via standardized physical examination.

Abnormal deviation of the tongue when extended (Yes, No) Difficulty extending the tongue left (Yes, No) Difficulty extending the tongue right(Yes, No) Difficulty extending the tongue up (Yes, No) Difficulty extending the tongue down (Yes, No)
7 days, 30 days and 90 days
Impact of Cryotherapy on Tongue Function: Swallowing
Time Frame: 7 days, 30 days and 90 days
Evaluated by Physician observation for overt signs of cough or other difficulty during trial swallows (e.g., water) or routine oral intake (Unremarkable or Abnormal, specify)
7 days, 30 days and 90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Measures: Home Sleep Apnea Testing (HSAT)
Time Frame: 90 days

The feasibility of using a Level 3 home sleep study will be evaluated. Two consecutive nights of home sleep testing will be collected.

The average Apnea Hypopnea Index (AHI) from the 2 nights of recording will be reported.
90 days
Exploratory Measures: Magnetic Resonance Image (MRI)
Time Frame: 45 and 90 days
An MRI image for fat quantitation without contrast will be collected to evaluate the fat content (% fat) in the treated zone.
45 and 90 days
Exploratory Measures: Patient Reported Outcome Measures
Time Frame: 2 days, 3 days, 7 days, 30 days, 45 and 90 days
Pain Visual Analog Scale (VAS) with ratings from 0 to 10; 0 being no pain and 10 is the worst possible pain.
2 days, 3 days, 7 days, 30 days, 45 and 90 days
Exploratory Measures: Patient Reported Outcome Measures
Time Frame: 30 and 90 days
Epworth Sleepiness Survey (ESS) that rates a daytime sleepiness on a scale of 0 to 22 with 22 being most sleepy as possible during the day. Patients rate on a 4-point scale (0 to 3, where 0 is no change of dozing and 3 a high chance of dozing) their usual chances of having dozed off or fallen asleep while engaged in eight different activities.
30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cryosa, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marquito Caballero, MD, Sanatorio Americano
  • Principal Investigator: Stella Rowley, MD, San Fernando Specialized Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10419 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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