Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA (ARCTIC-2)

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: CHILLS Procedure

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Panama City, Panama
    • Paitilla Medical Center
  • Panama City, Panama
    • Punta Pacifica Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; CHILLS Procedure	Device: CHILLS Procedure; Cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Testing	Change in Apnea Hypopnea Index from Baseline	90 days, 6-, 12- and 24-months
Epworth Sleepiness Survey (ESS)	Change in ESS from Baseline	90 days, 6-, 12-, 18- and 24-months
Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)	Change in FOSQ-10 from Baseline	90 days, 6-, 12-, 18- and 24-months
Pain Visual Analog Scale (VAS)	Rate oropharyngeal pain on VAS from 0 to 10; 0 being no pain and 10 is the worst possible pain	Discharge (day 1), 7 days, 30 days, 90 days and every 6 months through 2 years
Eating Assessment Tool (EAT-10)	EAT-10 is a self-administered 10 question symptom survey for dysphagia that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.	7 days, 30 days, 90 days and every 6 months through 2 years

Collaborators and Investigators

• Sponsor: Cryosa, Inc.
• Investigators: Principal Investigator: Stella Rowley, MD, San Fernando Specialized Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 10721 (Other Identifier: CTEP)

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