Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA

Study Overview
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Brief Summary
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ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.

Detailed Description
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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.

Official Title
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Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1

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: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 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>* CHILLS Cryotherapy procedure<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, or bleeding requiring surgical intervention or transfusion. | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Cryotherapy on Tongue Function: Taste | 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 | 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 | 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 | 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 |