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

NCT ID: NCT05542082

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-09-14

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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

CHILLS Procedure

Group Type: EXPERIMENTAL

CHILLS Procedure

Intervention Type: DEVICE

Cryotherapy

Interventions

CHILLS Procedure

Cryotherapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cryosa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stella Rowley, MD

Role: PRINCIPAL_INVESTIGATOR

San Fernando Specialized Center

Locations

Punta Pacifica Hospital

Panama City, Provincia de Panamá, Panama

Paitilla Medical Center

Panama City, , Panama

Countries

Panama

Other Identifiers

10721

Identifier Type: -

Identifier Source: org_study_id