An interventional study of CHILLS Procedure in Obstructive Sleep Apnea of Adult, sponsored by Cryosa, Inc.. Terminated at 2 sites in Panama. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Cryosa, Inc. · Not applicable, Interventional, and Treatment
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 22 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Cryosa, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CHILLS Procedure
Device: CHILLS Procedure
Cryotherapy
Incidence of Serious Procedure-Related Complications
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.
Time frame: 90 Days
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Jun 2023, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Cryosa, Inc.