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

Cryosa

Status

Active, not recruiting

Conditions

Obstructive Sleep Apnea of Adult

Treatments

Device: CHILLS Procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT05542082

10721

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

22 to 70 years old

Volunteers

No Healthy Volunteers

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