Cryosa Procedure for Obstructive Sleep Apnea
(ARCTIC-3 Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that could affect study results, such as benzodiazepines, Z-drugs, opiates, antipsychotics, phenothiazines, and prescription stimulants.
Is the Cryosa Procedure safe for humans?
There is a study on a cryosurgery unit named CRYO2, which is similar to the Cryosa Procedure, showing it was assessed for safety in treating airway obstructions. Additionally, a study on a method using ice-slurry for tongue fat reduction in a swine model suggested it could achieve low temperatures without causing harm, indicating potential safety in humans.12345
How does the Cryosa Procedure treatment for obstructive sleep apnea differ from other treatments?
The Cryosa Procedure is unique because it likely involves a cryogenic technique, which may target specific areas of the upper airway to reduce obstruction, unlike traditional methods like CPAP (continuous positive airway pressure) or more invasive surgeries. This approach could offer a less invasive alternative with potentially fewer side effects.678910
What data supports the effectiveness of the Cryosa Procedure treatment for obstructive sleep apnea?
The Cryosa Procedure may be similar to cryogenic plasma tonsillectomy, which is used to treat obstructive sleep apnea in children by removing tonsils to open the airway. Surgical approaches that enlarge the airway, like tonsillectomy, have shown success in treating obstructive sleep apnea by reducing airway collapsibility.611121314
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Cryosa procedure applied to the tongue and soft palate
Initial Follow-up
Participants are monitored for safety and effectiveness, with assessments at 7, 30, and 90 days post-procedure
Extended Follow-up
Long-term monitoring of safety and effectiveness with assessments at 6, 12, 18, and 24 months post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Cryosa Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cryosa, Inc.
Lead Sponsor