Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

Obstructive Sleep Apnea of Adult Clinical Trial

— ARCTIC-2  

Official title:

OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05542082
• Other study ID #: 10721
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Cryosa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 1, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CHILLS Procedure
Cryotherapy

Locations

Country	Name	City	State
Panama	Paitilla Medical Center	Panama City
Panama	Punta Pacifica Hospital	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Cryosa, Inc.

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Testing	Change in Apnea Hypopnea Index from Baseline	90 days, 6-, 12- and 24-months
Other	Epworth Sleepiness Survey (ESS)	Change in ESS from Baseline	90 days, 6-, 12-, 18- and 24-months
Other	Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)	Change in FOSQ-10 from Baseline	90 days, 6-, 12-, 18- and 24-months
Other	Pain Visual Analog Scale (VAS)	Rate oropharyngeal pain on VAS from 0 to 10; 0 being no pain and 10 is the worst possible pain	Discharge (day 1), 7 days, 30 days, 90 days and every 6 months through 2 years
Other	Eating Assessment Tool (EAT-10)	EAT-10 is a self-administered 10 question symptom survey for dysphagia that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.	7 days, 30 days, 90 days and every 6 months through 2 years
Primary	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.	90 Days