Obstructive Sleep Apnea of Adult
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICECHILLS Procedure
Cryotherapy
Sponsors
Cryosa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Procedure-Related Complications | 90 Days | 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; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 \< 70% for \> 10% of sleep. |
Countries
Panama
Outcome results
None listed