Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA (ARCTIC-2)
Obstructive Sleep Apnea of Adult
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult
Eligibility Criteria
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
Sites / Locations
- Paitilla Medical CenterRecruiting
- Punta Pacifica HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Single Arm
CHILLS Procedure