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

Last updated: May 30, 2024
Sponsor: Cryosa, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

CHILLS Procedure

Clinical Study ID

NCT05542082
10721
  • Ages 22-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: CHILLS Procedure
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
April 01, 2027

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.

Connect with a study center

  • Paitilla Medical Center

    Panama City,
    Panama

    Site Not Available

  • Punta Pacifica Hospital

    Panama City,
    Panama

    Site Not Available

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