Cryosa Procedure for Obstructive Sleep Apnea
(ARCTIC-3 Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cryosa, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Eligibility Criteria

Adults aged 22-70 with moderate to severe obstructive sleep apnea who can't or won't use PAP or MAD devices, have a BMI of ≤ 40 kg/m2, and are non-smokers. They must be able to consent and live near the study site. Exclusions include general anesthesia risks, recent upper airway surgery, resistant hypertension, certain heart conditions, neuromuscular diseases, active severe lung disease including COVID-19 complications.

Inclusion Criteria

I likely have or am diagnosed with severe sleep apnea.

I cannot or will not use devices like CPAP or mouthpieces for sleep apnea.

I am between 22 and 70 years old.

+3 more

Exclusion Criteria

I do not have severe lung blood vessel problems like high blood pressure in lungs or clots.

I have severe kidney failure and am on or will need dialysis soon.

My diabetes is not under control, with an HbA1c level over 9.

+28 more

Participant Groups

The Cryosa procedure is being tested for safety and effectiveness in treating obstructive sleep apnea (OSA). This single-arm study involves participants with moderate to severe OSA who will undergo the procedure and then be monitored to assess its performance over time.

1Treatment groups

Experimental Treatment

Group I: Cryosa ProcedureExperimental Treatment1 Intervention

The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).