Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

Study Overview
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Brief Summary
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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
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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.

Official Title
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OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Device: CHILLS Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>CHILLS Procedure | Device: CHILLS Procedure<br>* Cryotherapy<br>|

What is the study measuring?
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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 |